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

Catalog Number BXAL083902A

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi information: (b)(4).Results code: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2018, a patient was undergoing an arterio-venous outflow procedure with a gore® viabahn® vbx balloon expandable endoprosthesis.Access was obtained from the left groin.The device was advanced over a.035" rosen wire through a 7fr.Cook flexor sheath.During advancement to the desired location in the left arm, the device was not tracking well.It was decided the device would be removed.When the device was attempted to be re-sheathed, the edge of the stent became caught.The device came off the balloon and was left in the left iliac vessel where it landed.A longer sheath was then inserted and a viabahn device was advanced and deployed in the desired location.The patient did well following the procedure.

Manufacturer Narrative

A voluntary medwatch was submitted to the fda.

• 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: 7219020
• MDR Text Key: 98433467
• Report Number: 2017233-2018-00050
• 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
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2020
• Device Catalogue Number: BXAL083902A
• Device Lot Number: 17371196
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1