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

Model Number 10620

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.During a procedure involving a 3.00 x 24 synergy drug eluting stent, the balloon ruptured making it necessary for a new stent to be implanted.There was no harm to the patient and the patient condition following the procedure was stable.

Event Description

It was reported that a balloon rupture occurred.During a procedure involving a 3.00 x 24 synergy drug eluting stent, the balloon ruptured making it necessary for a new stent to be implanted.There was no harm to the patient and the patient condition following the procedure was stable.

Manufacturer Narrative

The synergy ous mr 3.00 x 24mm stent delivery system was returned for analysis.Visual/tactile inspection showed a hypotube break directly at the strain relief.No issues were noted with the outer and inner lumen and the mid-shaft section.Microscopic inspection revealed no sign of stent damage or stent movement.No issues were noted with the balloon or the tip.The balloon was inflated to 16 atm with no issues.

• 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: 18193416
• MDR Text Key: 328818245
• Report Number: 2124215-2023-66108
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0030555793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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