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	H7493926024270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(6) study.It was reported that a vessel perforation occurred.In (b)(6) 2016, the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was located in distal left circumflex (lcx) artery extending to second oblique marginal artery(om) wih 90% stenosis and was a 20mm long with a reference vessel diameter of 2.5mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50 x 20 mm synergy ii drug-eluting stent (des).Following post dilatation, the residual stenosis was 0% with timi 3 flow.Target lesion #2 was located in proximal lcx extending to distal lcx with 80% stenosis and was 20 mm long with a reference vessel diameter of 2.75 mm.Target lesion #2 was treated with pre-dilatation and placement of a 2.75 x 20 mm synergy ii des with 0% residual stenosis and timi 3 flow.Target lesion #3 was located in mid right coronary artery (rca) with 90% stenosis and was 12 mm long with a reference vessel diameter of 2.25 mm.Target lesion #3 was treated with pre-dilatation and placement of a 2.25 x 12 mm synergy ii des with 0% residual stenosis and timi 3 flow.However, a perforation was noted post index procedure.The following day, the patient was discharged on dual antiplatelet therapy.

• 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: 6117874
• Report Number: 2134265-2016-10443
• Device Sequence Number: 830488
• Product Code: NIQ
• UDI-Device Identifier: 08714729840220
• UDI-Public: (01)08714729840220(17)20170425(10)19213890
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2016

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: 04/25/2017
• Device Model Number: H7493926024270
• Device Catalogue Number: 39260-2427
• Device Lot Number: 19213890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2016
• Initial Report FDA Received Date: 11/21/2016
• 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: Required Intervention
• Patient Age: 86 YR