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); Thrombosis (2100)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
Same case as: 2134265-2017-03311.It was reported that stent thrombosis occurred and the patient expired.Two synergy ii stents; a 3.50 x 12 and a 2.25 x 16 were implanted in the left anterior descending artery.Following the procedure, stent thrombosis occurred and the patient expired shortly thereafter.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Describe event or problem updated.(b)(4).
Event or Problem Description
It was further reported that the patient presented to the er with chest pain and was sent to the cardiac catheterization lab (ccl) and diagnosed with an st elevated myocardial infarction.After the synergy stents were implanted, the patient returned to the ccl with increasing chest pain.The physician indicated that the patient was "very sick.".

• 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: 6479505
• Report Number: 2134265-2017-03312
• Device Sequence Number: 13665561
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: (01)08714729840060(17)20171109(10)19985078
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 11/09/2017
• Device Model Number: H7493926012350
• Device Catalogue Number: 39260-1235
• Device Lot Number: 19985078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/17/2017
• 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