MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC EXPRESS SD RENAL/BILIARY STENT; STENT, RENAL

Model Number H74937911515150

Patient Problem Failure of Implant (1924)

Event Type  Other  

Event Description

Stent came off of balloon shaft intended for left renal artery.Was captured into tour guide sheath per md and was deployed into right ileac artery.

• Brand Name: BOSTON SCIENTIFIC EXPRESS SD RENAL/BILIARY STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18131866
• MDR Text Key: 328227004
• Report Number: MW5148098
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: H74937911515150
• Device Lot Number: 31582511
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1