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

Model Number BXA085901A

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

Based on the information known at this time, the device failed to deploy for the physician during the procedure.A new device was readily available and used without further incident.No harm to the patient.

• 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.; flagstaff AZ 86004
• MDR Report Key: 12480902
• MDR Text Key: 271753100
• Report Number: 12480902
• Device Sequence Number: 1
• Product Code: PRL
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BXA085901A
• Device Catalogue Number: BXA085901A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Date Report to Manufacturer: 09/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA