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Detail Report Supplemental Update Report CR Number: 2015086089 Implementation Date: 09-Jun-15 Related CR: 2015086089 MedDRA Change Requested Add a New LLT Final Disposition Final Placement Code # Proposed LLT In stent-graft occlusion Rejected After Suspension MSSO The proposal to add a new LLT In stent-graft occlusion is not approved after suspension. The MSSO will refrain from adding device related concepts with a high degree of Comment: granularity because it not feasible to accommodate every specific name/type of device as a unique MedDRA term. Instead, five PTs – PT Vascular stent thrombosis, PT Vascular stent occlusion, PT Vascular stent stenosis, PT Vascular stent restenosis, and PT Post angioplasty restenosis will be created to represent a broad concept to accommodate coding needs based on discussions with the submitter. CR Number: 2015086090 Implementation Date: 09-Jun-15 Related CR: 2015086090 MedDRA Change Requested Add a New LLT Final Disposition Final Placement Code # Proposed LLT In stent-graft reocclusion Rejected After Suspension MSSO The proposal to add a new LLT In stent-graft reocclusion is not approved after suspension. The MSSO will refrain from adding device related concepts with a high degree of Comment: granularity because it not feasible to accommodate every specific name/type of device as a unique MedDRA term. Instead, five PTs – PT Vascular stent thrombosis, PT Vascular stent occlusion, PT Vascular stent stenosis, PT Vascular stent restenosis, and PT Post angioplasty restenosis will be created to represent a broad concept to accommodate coding needs based on discussions with the submitter. CR Number: 2015086093 Implementation Date: 09-Jun-15 Related CR: 2015086093 MedDRA Change Requested Add a New LLT Final Disposition Final Placement Code # Proposed LLT Bare metal stent occlusion Approved After Suspension Proposed LLT Bare metal stent occlusion 10077147 Current To PT Vascular stent occlusion 10077143 MSSO The proposal to add a new LLT Bare metal stent occlusion is approved as requested after suspension. Bare metal stent occlusion is a recognized concept and will be Comment: added as sub-concept LLT to new PT Vascular stent occlusion. In related changes, new PT Vascular stent occlusion will be added to represent a broad concept to accommodate more granular LLTs. PT Vascular stent occlusion will be added to primary HLT Vascular complications associated with device; secondary HLT Non-site specific necrosis and vascular insufficiency NEC. In addition, the following LLTs will be moved to new PT Vascular stent occlusion - LLT Arterial stent occlusion, LLT Coronary stent occlusion LLT Vascular stent-graft occlusion, and LLT Vascular stent-graft reocclusion from PT Device occlusion. Jun-18-2015 Page 1 of 701 Supplemental Update Report CR Number: 2015159003 Implementation Date: 08-Jun-15 Related CR: 2015086093 MedDRA Change Requested Add a New PT Final Disposition Final Placement Code # Proposed PT Vascular stent occlusion Approved as Requested Proposed PT HLT primary Vascular complications associated with device Vascular stent occlusion 10077143 SOC primary General disorders and administration site HLT primary conditions Vascular complications 10069789 associated with device SOC primary General disorders and 10018065 administration site conditions HLT secondary Non-site specific necrosis and 10029558 vascular insufficiency NEC SOC secondary Vascular disorders 10047065 MSSO Comment: CR Number: 2015159004 Implementation Date: 08-Jun-15 Related CR: 2015086093 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Arterial stent occlusion Approved as Requested Proposed LLT From PT Device occlusion Arterial stent occlusion 10067794 Current To PT Vascular stent occlusion From PT Device occlusion 10064685 To PT Vascular stent occlusion 10077143 MSSO Comment: Jun-18-2015 Page 2 of 701 Supplemental Update Report CR Number: 2015159005 Implementation Date: 08-Jun-15 Related CR: 2015086093 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Coronary stent occlusion Approved as Requested Proposed LLT From PT Device occlusion Coronary stent occlusion 10051172 Current To PT Vascular stent occlusion From PT Device occlusion 10064685 To PT Vascular stent occlusion 10077143 MSSO Comment: CR Number: 2015159006 Implementation Date: 08-Jun-15 Related CR: 2015086093 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Vascular stent-graft occlusion Approved as Requested Proposed LLT From PT Device occlusion Vascular stent-graft occlusion 10076845 Current To PT Vascular stent occlusion From PT Device occlusion 10064685 To PT Vascular stent occlusion 10077143 MSSO Comment: CR Number: 2015159007 Implementation Date: 08-Jun-15 Related CR: 2015086093 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Vascular stent-graft reocclusion Approved as Requested Proposed LLT From PT Device occlusion Vascular stent-graft reocclusion 10076855 Current To PT Vascular stent occlusion From PT Device occlusion 10064685 To PT Vascular stent occlusion 10077143 MSSO Comment: Jun-18-2015 Page 3 of 701 Supplemental Update Report CR Number: 2015086094 Implementation Date: 09-Jun-15 Related CR: 2015086094 MedDRA Change Requested Add a New LLT Final Disposition Final Placement Code # Proposed LLT Bare metal stent reocclusion Approved After Suspension Proposed LLT Bare metal stent reocclusion 10077148 Current To PT Vascular stent occlusion 10077143 MSSO The proposal to add a new LLT Bare metal stent reocclusion is approved as requested after suspension. Bare metal stent reocclusion is a recognized concept and will be Comment: added as sub-concept LLT to new PT Vascular stent occlusion. CR Number: 2015086103 Implementation Date: 09-Jun-15 Related CR: 2015086103 MedDRA Change Requested Add a New LLT Final Disposition Final Placement Code # Proposed LLT Bare metal stent thrombosis Approved After Suspension Proposed LLT Bare metal stent thrombosis 10077149 Current To PT Vascular stent thrombosis 10063934 MSSO The proposal to add a new LLT Bare metal stent thrombosis is approved as requested after suspension. Bare metal stent thrombosis is a recognized concept and will be Comment: added as a sub-concept LLT to promoted PT Vascular stent thrombosis. In related changes, LLT Vascular stent thrombosis will be promoted to a PT under primary HLT Vascular complications associated with device; secondary HLT Non-site specific necrosis and vascular insufficiency NEC to provide a broader concept to accommodate more granular LLTs. In addition, LLT Aortic stent-graft thrombosis, LLT Coronary stent thrombosis, LLT Renal stent-graft thrombosis, LLT Stent thrombosis, LLT Stent-graft thrombosis, LLT Subclavian stent thrombosis and LLT Vascular stent-graft thrombosis will be moved from PT Thrombosis in device to newly promoted PT Vascular stent thrombosis. Jun-18-2015 Page 4 of 701 Supplemental Update Report CR Number: 2015159008 Implementation Date: 08-Jun-15 Related CR: 2015086103 MedDRA Change Requested Promote an LLT Final Disposition Final Placement Code # Proposed LLT Vascular stent thrombosis Approved as Requested Proposed LLT From PT Thrombosis in device Vascular stent thrombosis 10063934 HLT primary Vascular complications associated with device From PT Thrombosis in device 10062546 HLT primary Vascular complications 10069789 associated with device SOC primary General disorders and 10018065 administration site conditions HLT secondary Non-site specific necrosis and 10029558 vascular insufficiency NEC SOC secondary Vascular disorders 10047065 MSSO Comment: CR Number: 2015159009 Implementation Date: 08-Jun-15 Related CR: 2015086103 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Aortic stent-graft thrombosis Approved as Requested Proposed LLT From PT Thrombosis in device Aortic stent-graft thrombosis 10064397 Current To PT Vascular stent thrombosis From PT Thrombosis in device 10062546 To PT Vascular stent thrombosis 10063934 MSSO Comment: Jun-18-2015 Page 5 of 701 Supplemental Update Report CR Number: 2015159010 Implementation Date: 08-Jun-15 Related CR: 2015086103 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Renal stent-graft thrombosis Approved as Requested Proposed LLT From PT Thrombosis in device Renal stent-graft thrombosis 10076857 Current To PT Vascular stent thrombosis From PT Thrombosis in device 10062546 To PT Vascular stent thrombosis 10063934 MSSO Comment: CR Number: 2015159011 Implementation Date: 08-Jun-15 Related CR: 2015086103 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Coronary stent thrombosis Approved as Requested Proposed LLT From PT Thrombosis in device Coronary stent thrombosis 10063933 Current To PT Vascular stent thrombosis From PT Thrombosis in device 10062546 To PT Vascular stent thrombosis 10063934 MSSO Comment: CR Number: 2015159012 Implementation Date: 08-Jun-15 Related CR: 2015086103 MedDRA Change Requested Link (move) an LLT to another PT Final Disposition Final Placement Code # Proposed LLT Stent thrombosis Approved as Requested Proposed LLT From PT Thrombosis in device Stent thrombosis 10076859 Current To PT Vascular stent thrombosis From PT Thrombosis in device 10062546 To PT Vascular stent thrombosis 10063934 MSSO Comment:
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