MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD MR 3.00X48MM; CORONARY DRUG-ELUTING STENT

Model Number H7493941848300

Device Problems Fracture (1260); Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

After the stent deployment and post dilation, it was found that was fractured and unraveled.

• Brand Name: SYNERGY XD MR 3.00X48MM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13839105
• MDR Text Key: 287535219
• Report Number: 13839105
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941848300
• Device Lot Number: 28082104
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1