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

Model Number 10623

Device Problem Obstruction of Flow (2423)

Patient Problems Atherosclerosis (1728); Reocclusion (1985); Thrombosis (2100); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 10/28/2020

Event Type  Injury  

Event Description

(b)(6) study. It was reported that in-stent restenosis occurred. In (b)(6) 2019, the subject was referred for cardiac catherization and on the same day index procedure was performed. The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 90% stenosis and was 35 mm long, with a reference vessel diameter of 3 mm. The target lesion was treated with pre-dilatation and placement of a 3. 00x38mm synergy stent system the residual stenosis was 0%. Post dilation was not performed. The following day, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment. The subject was diagnosed with coronary atherosclerotic heart disease. The following day, the subject was referred for coronary angiography which revealed 70% proximal to mid lad stenosis which was treated with drug balloon dilatation percutaneous coronary intervention - target vessel revascularization. Post intervention, residual stenosis was 0%. The following day, the subject was discharged on aspirin and clopidogrel.

• 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: 10932034
• MDR Text Key: 219129009
• Report Number: 2134265-2020-16765
• 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
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/15/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023575184
• 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: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• 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: 12/02/2020 Patient Sequence Number: 1