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); Thrombosis (2100)
Date of Event	11/14/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent thrombosis and death occurred.A 2.25 x 12mm synergy ii drug-eluting stent (des) was implanted in the posterior "desceding" artery (pda).Two stents were placed in the left circumflex artery, a 2.25 x 16mm synergy ii des and a 2.25 x 12mm synergy ii des.Twenty minutes after the patient was taken off the table, the patient experienced chest pain.Electrocardiography revealed stent thrombosis on the three implanted stents.The physician placed a 2.25 x 8mm stent distal to previously implanted stent in the pda.The following day, a non-bsc temporary ventricular support device was implanted in the proximal right coronary artery because the patient was in shock.After one day, the patient died.The physician believes that the patient had a neurological event prior to removing the non-bsc device.

• 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: 8143326
• Report Number: 2134265-2018-63554
• Device Sequence Number: 1621059
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/07/2018

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: 12/04/2018
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0021493195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPELLA VENTRICULAR SUPPORT DEVICE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR