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

Model Number H7493942824500

Device Problems Break (1069); Retraction Problem (1536)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/13/2023

Event Type  malfunction  

Event Description

During a transcatheter aortic valve replacement the stent delivery balloon was unable to come back into the guide.When attempting to retrieve, the balloon broke off the delivery system into the patient, which was retrieved by a snare.

• Brand Name: SYNERGY MEGATRON¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 17019253
• MDR Text Key: 316110677
• Report Number: 17019253
• 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: 05/17/2023,05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493942824500
• Device Lot Number: 30045957
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: Black Or African American