MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH070502W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

A review of the boxing records indicated the lot met all pre-release specifications.The device remains implanted, so evaluation of the actual device was unable to be completed.Images are available, and an imaging evaluation is in progress.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient was implanted with a 7mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface to treat abdominal aortic aneurysm with fenestration technique.After the viabahn device was advanced to renal artery and distal positioning, the physician withdrew the sheath and deployed the viabahn device.During deploying, it was found the viabahn device was shortened.Then angiography showed that the fenestration overlap between the viabahn device and aortic graft was not enough, resulting in serious endoleak.On (b)(6), another 7mm x 5cm viabahn device was used to cover endoleak.The endoleak disappeared after angiography.The patient tolerated the procedure.

Manufacturer Narrative

H6-3221: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The evaluation summary: one movie captured on a non-medical device, of an angiogram run on a monitor, received for evaluation.No name or full date can be visualized on images submitted.No lengths can be taken on angiogram imaging.The device implanted in what appears to be the aorta, is not a gore® device.There appears to be a stent in a possible visceral vessel.Cannot confirm a shortened device post deployment.There appears to be contrast outside the implanted devices.Cannot confirm device overlap or lack of, with available imaging.Endoleak of unknown origin.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10558222
• MDR Text Key: 207700747
• Report Number: 2017233-2020-01273
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Catalogue Number: VBH070502W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/20/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 10/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR