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	H7493926012350
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Death (1802); ST Segment Elevation (2059); Thrombosis (2100)
Date of Event	02/14/2017
Type of Reportable Event	Death
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
Same case as: 2134265-2017-01774 and 2134265-2017-01776.It was reported that the patient experienced thrombosis, chest pain, st elevations and expired.The patient presented with a st elevated myocardial infarction.The target lesion was located in the (b)(6) stenosed, mildly tortuous and mild to moderately calcified right coronary artery (rca).Three synergy ii stents were implanted overlapping in the rca; a 3.00 x 38 in the proximal to mid rca, another 3.00 x 38 in the mid rca, and a 3.50 x 12 in the distal rca.The procedure was completed and heparin bivalirudin, and clopidogrel blood thinning medication was administered.The patient was in recovery for 2-3 hours when chest pain and st elevations occurred.The patient was transferred back to the cardiac cath lab for treatment.The following day all 3 stents had complete thrombosis and angiojet thrombectomy was performed, however the patient expired.

• 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: 6393880
• Report Number: 2134265-2017-01777
• Device Sequence Number: 16271589
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: (01)08714729840060(17)20171004(10)19813574
• 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
• Report Date (Section B): 02/14/2017

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: 10/04/2017
• Device Model Number: H7493926012350
• Device Catalogue Number: 39260-1235
• Device Lot Number: 19813574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/09/2017
• 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