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

Catalog Number BXAL085902E

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2/a3/a4 as well as b7: further information was requested from the physician, but nothing was provided.H3: other code: the medical device is available, but was not returned for further investigation yet.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the device met pre-release specifications.Further investigation is being conducted and will be included in the final report.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 the patient underwent endovascular treatment for stenting the right internal iliac artery with a gore® viabahn® vbx balloon expandable endoprosthesis in the course of a cook zenith® branch endovascular graft- iliac bifurcation (zbis) surgery.It was stated that the puncture was made on the left side and stenting in cross-over technique by using a rosen guide wire and a cook sheath (8/55).During advancement of the stent in the sheath, while pushing the whole device forward, it got stuck and the balloon dislodged, but the stent remained in position.The device could not be used and was removed.Another device was used in the same procedure and could be implanted successfully.There was no report of patient harm and the patient is doing well.

Manufacturer Narrative

Engineering investigation: the engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.The complaint reports the stent becoming dislodged during advancement through the introducer sheath.The device was returned with the stent displaced distally about the balloon, with three instances of bent back apices that were consistent with withdrawal (i.E., distal-facing apices that were bent in the proximal direction).Based on the position of the stent about the balloon cover and its undeployed appearance, the engineering evaluation can conclude that the stent was dislodged during the procedure, thereby confirming the failure mode.In an effort clarify how far the vbx device advanced through the introducer sheath, a follow up inquiry was sent to the field associate.The field associate indicated there was uncertainty about how far the device tracked through the sheath.Based upon this uncertainty and the unknown origin of the bent back apices, a root cause cannot be established with the available information, nor can the failure be replicated /recreated since the state of the device is no longer representative of the as-received state (from the perspective of the user).

• 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: 18985554
• MDR Text Key: 338684995
• Report Number: 2017233-2024-04758
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXAL085902E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2023
• 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
• Patient Outcome(s): Required Intervention