MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926020220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/27/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that death occurred.In (b)(6) 2017, the subject was referred for elective cardiac catheterization.Target lesion #1 was located in the second obtuse marginal with 95% stenosis and was 12mm long with a reference vessel diameter of 2.25mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.25mm x 20mm study stent.Following post dilatation, the residual stenosis was 0%.In (b)(6) 2017, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2017, the subject died of unknown cause.
Additional Manufacturer Narrative
Bsc id: (b)(4).Tw: (b)(4).
Event or Problem Description
It was further reported in (b)(6) 2017, the cause of death was end stage renal disease and was not considered related to the study device.Per death certificate, the immediate cause of death was end stage renal disease or a consequence of type 2 diabetes.Other significant condition contributing to death was congestive heart failure.Per death certificate autopsy was not performed and the manner of death was natural.The subject died at home.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7466486
• Report Number: 2134265-2018-03515
• Device Sequence Number: 19239997
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 04/05/2018

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: 09/22/2017
• Device Model Number: H7493926020220
• Device Catalogue Number: 39260-2022
• Device Lot Number: 0019777663
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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: 63 YR