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

Model Number	10606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis (2100)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that chest pain and stent thrombosis occurred.The patient presented with st elevation myocardial infarction and a 2.75 x 32 synergy drug-eluting stent was deployed in the mid left anterior descending (lad) artery.Following intervention, the patient was sent to their room.However, the following day, patient had chest pain and stent thrombosis was observed in the mid lad.The vessel was dilated using a 3.0 x 12mm non-compliant balloon catheter and intravenous ultrasound was performed with no dissection notced and with timi 3 flow.A balloon pump was inserted and the patient was sent to bypass surgery.No further patient complications were reported and the patient is expected to fully recover.

• 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: 10750606
• Report Number: 2134265-2020-14480
• Device Sequence Number: 11514840
• Product Code: NIQ
• UDI-Device Identifier: 08714729840343
• UDI-Public: 08714729840343
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 06/08/2022
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0025616611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: Other