MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Catalog Number	BXAL083902A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: the doctor attempted to advance the 8mm x 39mm gore® viabahn® vbx balloon expandable endoprosthesis through a previously placed 8mm x 29mm gore® viabahn® vbx balloon expandable endoprosthesis and then up an over the bifurcation.As the doctor was manipulating the device (pushing and pulling) attempting to advance the device, he observed the stent had become dislodged from the catheter.The stent was on the wire so the doctor advanced a balloon into the stent and inflated it.While inflated the doctor pulled the stent back to overlap the previously implanted 8mm x 29mm gore® viabahn® vbx balloon expandable endoprosthesis and extend the previous coverage.The doctor then took another 8mm x 39mm and successfully advanced it to the target area and deployed it with no issues.The doctor reported there were no consequences to the patient.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8302706
• Report Number: 2017233-2019-00063
• Device Sequence Number: 10780774
• Product Code: NIO
• UDI-Device Identifier: 00733132637829
• UDI-Public: 00733132637829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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 Expiration Date: 11/08/2021
• Device Catalogue Number: BXAL083902A
• Device Lot Number: 20017761
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other