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

Model Number 10602

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100); Complaint, Ill-Defined (2331)

Event Date 09/14/2020

Event Type  Injury  

Event 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
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10727399
• MDR Text Key: 212757009
• Report Number: 2134265-2020-14309
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: 08714729840114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR