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

Model Number 10619

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

Patient Problem Angina (1710)

Event Date 06/14/2023

Event Type  Injury  

Event Description

It was reported that patient experienced unstable angina pectoris.On (b)(6), 2022, the subject presented with stable angina and was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion# 1 was located in the 1st diagonal with 80% stenosis and was 18 mm long, with a reference vessel diameter of 2.25 mm.The target lesion# 1 was treated with pre-dilatation and placement of a 2.25 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion# 2 was located in the left main coronary artery (lcma) extending up to distal left anterior descending artery (lad) with 80% stenosis and was 52 mm long, with a reference vessel diameter of 4.0 mm.The target lesion# 2 was treated with pre-dilatation and placement of a 4.0 mm x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Nine days later, the subject was discharged on aspirin and clopidogrel.On (b)(6), 2023, the subject was diagnosed with stable angina pectoris and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event and site confirmed the same.Seven days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting the event was considered to be recovering/resolving.No additional information would be available pertaining to the event at the moment.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17371630
• MDR Text Key: 319502265
• Report Number: 2124215-2023-36229
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0028225110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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): Other; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male