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

Model Number	10605
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Chest Pain (1776); Cardiac Enzyme Elevation (1838); Thrombosis (2100)
Date of Event	09/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent partial deployment, thrombosis, chest pain and elevated troponin occurred.On (b)(6) 2020, the 95% in-stent restenosed target lesion was located in the left anterior descending artery (lad).A 2.50 x 28 synergy drug-eluting stent was advanced for treatment.However, the patient experienced chest pain and acute stent thrombosis was noted in the mid lad and percutaneous transluminal coronary angioplasty (ptca) was performed.Three days later, the patient went to the emergency department and presented with chest pain and elevated troponin.Intravascular ultrasound showed that there was a malposition of the stent.Ptca was then performed with a non compliant balloon at high pressure.No further 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: 10727326
• Report Number: 2134265-2020-14229
• Device Sequence Number: 17008532
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024661654
• 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; Required Intervention
• Patient Age: 76 YR