MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10623

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

Patient Problems Death (1802); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Cardiogenic Shock (2262)

Event Date 09/24/2020

Event Type  Death  

Event Description

It was reported that st-segment elevation myocardial infarction and acute stent thrombosis occurred and the patient died.In (b)(6) 2020, the patient was treated for coronary artery disease for lesions in the proximal left anterior descending (lad) and circumflex (cx) arteries.A 3.00 x 38 synergy drug-eluting stent was implanted in the proximal lad and a 3.00 x 24 synergy drug-eluting stent was implanted in the mid cx.Both stents were post dilated under fluoro - no ivus.The procedure was considered successful and no patient complications were reported.On the following day, the patient was discharged with dual antiplatelet therapy of aspirin and clopidogrel.Two days post procedure, the patient suffered an out of hospital arrest with st-segment elevation myocardial infarction (stemi) and was admitted to the hospital in cardiogenic shock and was taken to the cath laboratory.The angiogram demonstrated acute stent thrombosis in both synergy stents that was implanted 2 days prior.Balloon angioplasty was performed on both stents; however, one vessel would perfuse with coronary flow and then would thrombose again.On the same day, the patient died.It was unknown if autopsy was performed.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 10682751
• MDR Text Key: 211431788
• Report Number: 2134265-2020-13751
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2021
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024934181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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): Death