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

Catalog Number BXA085901J

Device Problems Patient-Device Incompatibility (2682); Activation Failure (3270)

Patient Problem Aneurysm (1708)

Event Date 09/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient underwent endovascular treatment for an abdominal aortic aneurysm and bilateral iliac artery aneurysms.During the procedure, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was to be implanted in the left superior gluteal artery.The vbx device was advanced to the target lesion, and during the balloon inflation to expand the stent graft, the vbx device became partially unexpanded and appeared to be partially narrowed.Furthermore, during the inflation, the left superior gluteal artery ruptured at the distal side of the vbx device (distal side of the narrowed position).For hemostasis, in the internal iliac artery, balloon occlusion was performed in the stent graft which had been implanted proximally to the vbx device.Furthermore, an attempt was made to implant a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) at the ruptured site for hemostasis, but it could not be inserted due to the wire not passing through.The use of the viabahn device was discontinued before it was inserted into the patient body.The left inferior gluteal artery had already been coil embolized at the time of the stent graft implantation in the iliac artery during the same procedure.In addition, the left superior gluteal artery was also coil embolized, and intendedly resulting the left internal iliac artery being occluded.The patient tolerated the procedure.The fsa stated: the failure of expansion was thought to be due to the calcification since some calcification was observed in the vessels at the site of the partially unexpanded.Regarding the rupture, it is undeniable that the vbx device was oversized for the diameter (about 7.2 mm) of the vessel since the treatment plan was decided emergently, and this may have been the cause of the rupture.(b)(4).

Manufacturer Narrative

Code "other" was selected as the medical device remains implanted.Return not possible.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Due to no device return, an investigation could not be performed.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.

Manufacturer Narrative

Section h6: investigation findings and investigation conclusions codes were updated to reflect the results of the investigation.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15612819
• MDR Text Key: 301821764
• Report Number: 2017233-2022-03410
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2024
• Device Catalogue Number: BXA085901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Male