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

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.B3: as the date of event is unknown, the date gore was made aware was used as date of event.Product history review: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.H3: other code: as the device remains implanted, a further investigation cannot be conducted.Further information was requested from the physician, like date of event, lot-/serial number and patient history, but no further details were made available.No parts are available for further investigation, but an image was provided and an engineering evaluation will be performed.Cbas® heparin surface incorporates carmeda-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported to gore that on an unknown date, a patient presenting with an abdominal aortic aneurysm was treated with fenestrated endovascular aortic aneurysm repair using a gore® viabahn® vbx balloon expandable endoprosthesis as a bridging stent.On (b)(6) 2024, in a control ct, imaging showed that the device appeared to be divided into two parts.In an angiography later this was confirmed.The patient was treated with re-stenting with a gore® viabahn® vbx balloon expandable endoprosthesis.The patient tolerated the procedure.The physician stated that the patient had a latent infection in aortic graft and that he doubts that the infection damaged vbx's eptfe layer & stent rings which caused the device to divide into two parts.

Manufacturer Narrative

Imaging evaluation: summary: 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 imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one jpg submitted for evaluation.Unable to manipulate the image in anyway.Unable to confirm a strut fracture of separation of device with available image.With the information provided to gore, the cause of the reported event cannot be established.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18949489
• MDR Text Key: 338242278
• Report Number: 2017233-2024-04726
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: FI
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK FEVAR GRAFT.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male