MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDO; ILIAC COVERED STENT, ARTERIAL

Model Number	BXAL083902A
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male patient with hypertension (htn), hypercholesterolemia, disabling claudication, peripheral arterial disease, rest pain and aortoiliac occlusive disease.Admitted for stenting of left (l) external ilic artery as well as the distal l common iliac artery, angioplasty of l common femoral and right (r) common femoral artery.Problem: "vbx stent is suppose to go through 7 f sheath and was unable to pass through the 7f" stent was removed in entirety.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDO
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st; flagsaff AZ 86004
• MDR Report Key: 9458214
• Report Number: 9458214
• Device Sequence Number: 3094859
• Product Code: PRL
• UDI-Device Identifier: 00733132637829
• UDI-Public: (01)00733132637829
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/04/2019
• Report Date (Section F): 12/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: BXAL083902A
• Device Catalogue Number: BXAL083902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 97
• Date Report Sent to FDA: 12/04/2019