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)

Event Date 11/16/2020

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that in-stent restenosis occurred.In (b)(6) 2020, the subject presented with unstable angina.Subsequently, the subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) with 70% stenosis and was 35 mm long, with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00mmx38 mm synergy stent system.Following post dilatation, residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with symptoms of coronary atherosclerotic heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The following day, coronary angiography revealed 95% stenosis in proximal lad which had previously placed study device and it was treated with percutaneous coronary intervention (target vessel revascularization).Post intervention, residual stenosis was 0%.At the time of reporting, the event was considered to be recovering/resolving.One day post intervention, 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: 10988241
• MDR Text Key: 220896390
• Report Number: 2134265-2020-17381
• 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: Physician
• Type of Report: Initial
• Report Date: 12/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023899954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR