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

Model Number	10602
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Chest Pain (1776); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)
Date of Event	07/24/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that thrombosis occurred, the patient had chest pain, dyspnea, st segment elevation myocardial infarction (stemi) and died.Left heart catheterization was performed and four synergy ii stents were implanted (lot # 22004570 ramus, lot # 21857814 ramus, lot #21929876 circumflex, lot # 21644587 left anterior descending artery).Intravascular ultrasound was not used pre or post intervention.Within 4 hours, the patient had chest pain, dyspnea and stemi and was brought back to the catheterization lab.Access was obtained and an attempt was made to visualize the coronary arteries; only the left main artery was visible due to a large thrombus at the left main artery (lm).None of the stent were believed to be open.The physician was not able to get the guidewire down any of the vessels except the circumflex.Thrombus was seen in the stent implanted in the circumflex.The circumflex was ballooned.The patient died during the procedure.

• 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: 7790190
• Report Number: 2134265-2018-60131
• Device Sequence Number: 1175405
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 04/06/2019
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0022004570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/16/2018
• 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