MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA¿; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number H74939294601210

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

During surgery, stent broke, and a piece could not be retrieved.Resulted in an unretrieved device fragment.No known harm to patient.

• Brand Name: ELUVIA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15469861
• MDR Text Key: 300458369
• Report Number: 15469861
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 27949170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Date Report to Manufacturer: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22265 DA
• Patient Sex: Male