MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10601
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/08/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that a death had occurred.In (b)(6) 2017 the subject presented with stable angina and was further referred for cardiac catheterization.Target lesion #1 was located in proximal left circumflex artery with 95% stenosis and was 8 mm long with a reference vessel diameter of 4mm.The lesion was treated with direct placement of a 4.00 x 20 study stent.Following, post dilatation, the residual stenosis was 0%.Target lesion #2 was located in proximal right coronary artery with 90% stenosis and was 4 mm long with a reference vessel diameter of 3.8mm.The lesion was treated with pre-dilatation and placement of a 4.00x12 study stent.Following, post dilatation, the residual stenosis was 10%.That same day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2018 the patient died.The cause of death is unknown and it is unknown if an autopsy was performed.
Additional Manufacturer Narrative
Device is a combination product.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 09:00 am ct.The report number is being corrected from: 2134265-2018-63925 to: 2134265-2018-61817.
Event or Problem Description
Evolve short dapt clinical study it was reported that a death had occurred.In (b)(6) 2017 the subject presented with stable angina and was further referred for cardiac catheterization.Target lesion #1 was located in proximal left circumflex artery with 95% stenosis and was 8 mm long with a reference vessel diameter of 4mm.The lesion was treated with direct placement of a 4.00 x 20 study stent.Following, post dilatation, the residual stenosis was 0%.Target lesion #2 was located in proximal right coronary artery with 90% stenosis and was 4 mm long with a reference vessel diameter of 3.8mm.The lesion was treated with pre-dilatation and placement of a 4.00x12 study stent.Following, post dilatation, the residual stenosis was 10%.That same day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2018 the patient died.The cause of death is unknown and it is unknown if an autopsy was performed.It was further reported the patients death was reported during a telephone conversation with a family member, who did not wish to disclose further information.Stent thrombosis was also reported as possible through adjudication.
Additional Manufacturer Narrative
Device is a combination product.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 01/11/2019 10:02 am ct.The report number is being corrected from 2134265-2018-63925 to 2134265-2018-61817.
Event or Problem Description
(b)(6) clinical study.It was reported that a death had occurred.In (b)(6) 2017 the subject presented with stable angina and was further referred for cardiac catheterization.Target lesion #1 was located in proximal left circumflex artery with 95% stenosis and was 8 mm long with a reference vessel diameter of 4mm.The lesion was treated with direct placement of a 4.00 x 20 study stent.Following post dilatation, the residual stenosis was 0%.Target lesion #2 was located in proximal right coronary artery with 90% stenosis and was 4 mm long with a reference vessel diameter of 3.8mm.The lesion was treated with pre-dilatation and placement of a 4.00x12 study stent.Following post dilatation, the residual stenosis was 10%.That same day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2018 the patient died.The cause of death is unknown and it is unknown if an autopsy was performed.It was further reported the patients death was reported during a telephone conversation with a family member, who did not wish to disclose further information.Stent thrombosis was also reported as possible through adjudication.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7966594
• Report Number: 2134265-2018-61817
• Device Sequence Number: 182798
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2018
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0020611381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 12/16/2018; 12/16/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 01/25/2019; 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR