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

Model Number BXAL083902A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/02/2019

Event Type  malfunction  

Event 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
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st; flagsaff AZ 86004
• MDR Report Key: 9458214
• MDR Text Key: 170490390
• Report Number: 9458214
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637829
• UDI-Public: (01)00733132637829
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 97