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

Model Number	10602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis (2100); Complaint, Ill-Defined (2331)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that myocardial infarction, right ventricular failure and acute stent thrombosis occurred.In (b)(6) 2020, the patient was admitted with spinal stenosis and underwent surgery.The target lesions were located in the left anterior descending (lad) with 70% stenosis, circumflex (cx) with 90% stenosis, and right coronary arteries (rca) with 95% stenosis.A 2.75x20mm and 3.0x16mm synergy drug-eluting stents were implanted in the rca.After the surgery, the patient was taken to the post-anesthesia care unit (pacu); however, the patient suffered from myocardial infarction.On the following day, the patient was taken back to the cardiac catherization lab and found to have an acute stent thrombosis in both synergy stents in the rca that was implanted 1 day prior.Balloon angioplasty was performed and stented with non-boston scientific stents.The patient experienced right ventricular failure and received impella and extracorporeal membrane oxygenation (ecmo) and was still admitted.

• 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: 10727399
• Report Number: 2134265-2020-14309
• Device Sequence Number: 3457441
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: 08714729840114
• 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: 01/26/2022
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0025167160
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR