MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. VIABAHN ENDOPROSTHESIS COVERED STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number VBHR110502A

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

Patient went for a left leg angiogram and stent placement.During the procedure one of the stents only partially deployed and was removed but got lodged at the right common femoral arteriotomy necessitating a cutdown.Fda safety report id # (b)(4).

• Brand Name: VIABAHN ENDOPROSTHESIS COVERED STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.
• MDR Report Key: 14257471
• MDR Text Key: 290520908
• Report Number: MW5109434
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132646081
• UDI-Public: (01)00733132646081
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: VBHR110502A
• Device Catalogue Number: VBHR110502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White