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

Catalog Number BXA051902E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Stenosis (2263)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

No part will be made available for further investigation.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment for a stenosis in the inferior mesenteric artery with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that the physician tried to advance the catheter through the aorta to the mesenteric artery.As the curve of the artery was very close, he didn¿t succeed to enter the artery.It was reported that he tried to push the catheter with the help of the tip of the introducer sheath, but at that moment the vbx-device disconnected from the catheter.It was stated that the physician retook the vbx-device with a recovery clamp.Reportedly, there was no report of patient harm and the procedure will be repeated next week by arm access.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to phr-review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Product investigation report conclusion: use of the vbx device outside the ifu is considered probable cause for this complaint.Gore did not receive the explanted device, and information regarding the device form was not available.A product history review was conducted and shows the device met pre-release manufacturing specifications.The investigation confirms the complaint of an endoprosthesis that separated from the device.The probable cause is the reported attempt to use the sheath, outside ifu, to act upon the device to aid in reaching the target lesion.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11026741
• MDR Text Key: 223593330
• Report Number: 2017233-2020-01534
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Catalogue Number: BXA051902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR