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

Model Number	VBJR070502A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While performing an angiogram, the physician attempted to place a stent in the splenic artery.He was unable to get accurate placement; therefore, he removed the catheter with the stent undeployed.He experienced difficulty pulling the catheter out and once the catheter was out, he noticed the catheter, where it attaches to the stent, was broken.Nothing was left in the body.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth street; flagstaff AZ 86004
• MDR Report Key: 20842148
• Report Number: 20842148
• Device Sequence Number: 17125991
• Product Code: NIP
• UDI-Device Identifier: 00733132623761
• UDI-Public: (01)00733132623761
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024
• Report Date (Section F): 11/25/2024

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 Model Number: VBJR070502A
• Device Catalogue Number: VBJR070502A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Date Report Sent to FDA: 11/25/2024