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

Model Number 10617

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

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Vascular Dissection (3160)

Event Date 03/24/2023

Event Type  Injury  

Event Description

It was reported that dissection occurred.The patient presented for a percutaneous transluminal coronary angioplasty (ptca).The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).Following predilatation with a 2.5 x 8mm semi compliant balloon, a 3.00 x 12mm synergy drug eluting stent was deployed at 11 atmospheres to treat the lesion.During proximal optimisation technique (pot) with a 3 x 8 non-compliant balloon, which was 3 in diameter inflated at nominal burst pressure (nbp), a dissection at the distal edge of the stent was noted.The st elevation and chest pain occurred related to the dissection.Another 2.50 x 8 mm synergy stent was deployed to cover the dissection, then proximal optimisation technique (pot) with a 2.5 x 8 balloon at nominal pressure 6 atmospheres, and successfully complete the procedure.The patient was stable, well condition, and no angina post procedure.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16942517
• MDR Text Key: 315334666
• Report Number: 2124215-2023-24309
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0029556801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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): Required Intervention