MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD 3.5 X 32 STENT; CORONARY DRUG-ELUTING STENT

Lot Number 32374111

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Stent deployed in artery, but would not release from balloon.

• Brand Name: SYNERGY XD 3.5 X 32 STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18940735
• MDR Text Key: 338239881
• Report Number: MW5152994
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 32374111
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male