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

Model Number 10622

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atherosclerosis (1728); Reocclusion (1985); Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 08/19/2020

Event Type  Injury  

Event Description

(b)(6) registry clinical. It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease. In (b)(6) 2019, the subject presented with unstable angina. The subject was referred for cardiac catheterization and on the same day, the index procedure was performed. The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2. 50 mm. The lesion was treated with pre-dilatation and placement of a 2. 50 x 32 mm synergy stent system. Following post-dilatation, the residual stenosis was 0%. Two days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2020, the subject presented with symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment. The subject was diagnosed with coronary atherosclerotic heart disease. The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.

• 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: 10817455
• MDR Text Key: 215537074
• Report Number: 2134265-2020-15616
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/02/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023325130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/10/2020 Patient Sequence Number: 1