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

Model Number	10601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent thrombosis occurred and the patient experienced chest pain.The patient was presented with myocardial infarction.The target lesions were located in the total distal right coronary (rca) and left anterior descending (lad) arteries with 80% mid and 90% distal stenosis.A 2.5x24 synergy drug-eluting stent (des) was implanted in the rca and a 2.75x12 synergy des was successfully placed in the lad.However, one hour later post procedure, the patient experienced chest pain after electrocardiogram changes and acute stent thrombosis was noted on the distal rca where stent was implanted.Angioplasty was performed with emerge balloon catheter and the procedure was completed.No further patient complications were reported and the patient was discharged home.

• 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: 10727317
• Report Number: 2134265-2020-14352
• Device Sequence Number: 3456868
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: 08714729840046
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/23/2020

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: 03/26/2022
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0025446322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/23/2020
• 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
• Patient Age: 42 YR