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

Model Number 10621

Device Problem Obstruction of Flow (2423)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 06/13/2021

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that stable angina and restenosis occurred.In (b)(6) 2019, the subject with stable angina was referred for cardiac catherization and the index procedure was performed on the same day.The target lesion 1 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 39 mm long, with a reference vessel diameter of 4.00 mm.The target lesion 1 was treated with pre-dilatation followed by placement of 3.50 mm x 16 mm overlapped with 4.00 mm x 28 mm synergy stents system.Following post-dilatation, the residual stenosis was 0%.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject presented with angina and symptoms of ischemia was diagnosed with stable angina pectoris and was hospitalized on the same day for further evaluation and treatment.Two days later, the subject was referred for coronary angiography which revealed 95% stenosis noted in proximal lad extended to distal lad which had previously placed study device in mid lad was treated with percutaneous coronary intervention (pci), target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.At the time of reporting, the outcome of the event was considered to be recovering and resolving.Two days later, 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: 12558510
• MDR Text Key: 274232607
• Report Number: 2134265-2021-12184
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2020
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0022444599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• 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; Other; Required Intervention
• Patient Age: 37 YR