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

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Occlusion (1984)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.It is unclear if the implanted device was gore® viabahn® vbx balloon expandable endoprosthesis or gore® viabahn® endoprosthesis (ref medwatch #2017233-2020-00027).

Event Description

Published abstract "two-year evaluation of fenestrated and parallel branch endografts for the treatment of juxtarenal, suprarenal, and thoracoabdominal aneurysms at a single institution" (mohsen bannazadeh, m.D., william e.Beckerman, m.D., adam h.Korayem, m.D., and james f.Mckinsey, m.D., new york, ny; copyright 2019 published by elsevier inc.On behalf of the society for vascular surgery; https://doi.Org/10.1016/j.Jvs.2019.03.058) was reviewed.The abstract discusses the mortality, graft patency, renal function, complication, and reintervention rates for fenestrated and parallel endografts in complex aortic aneurysms repairs from august 2014 to march 2017 in a single center.The abstract reported in the reintervention, branch reintervention, and endoleaks section one renal stent graft kinked.It is unclear if the implanted device was gore® viabahn® vbx balloon expandable endoprosthesis or gore® viabahn® endoprosthesis.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9582841
• MDR Text Key: 186206552
• Report Number: 2017233-2020-00028
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR