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

Catalog Number BXA073902J

Device Problems Break (1069); Activation Failure (3270); Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

Code "other" was selected as the medical device remains implanted.Return not possible.Use of an additional or alternative device was required to achieve optimal outcome.Problem associated with the device failing to be activated including partial activation.Problem with all or part of an implanted or invasive device moving from its intended location within the body.Tubular support placed inside a blood vessel, canal, or duct to aid healing or relieve an obstruction.The investigation involved communication/interviews (either interpersonal or through technical means, e.G.Phone, e-mail) with persons close to the adverse event, e.G.Healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.Medical device remains implanted.No investigation can be performed (no serial number available and no device return), therefore no results will be obtained.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

Event Description

The following information was reported to gore: on (b)(6) 2022, this patient underwent a thoracic endovascular aortic repair with chimney technic using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device / 7-39).The vbx device was to be implanted in the left subclavian artery.After implanting a non-gore stent graft (cook zenith alpha ®) in the aorta, the vbx device was deployed at the target site.The distal side of the vbx stent graft was expanded, but the proximal side of the vbx stent graft was not expanded.The balloon of the vbx device was thought to be ruptured, and the vbx balloon was attempted to remove, but it didn¿t succeed.After it became a little easier to remove with the attempts of poking the vbx device using a tip of a non-gore balloon (6mm-2cm) several times, the vbx balloon was finally removed from the patient.However, when the vbx balloon was removed, the vbx stent graft migrated.The unexpanded part of the vbx stent graft was expanded with again using a non-gore balloon (6 mm-2 cm), but it was not fully expanded since the balloon diameter was 6 mm.Subsequently, another vbx device (8l-59) was additionally deployed to cover the area where the first vbx stent graft had migrated, and at that time, the first vbx stent graft was fully expanded.Reportedly, the removed vbx balloon was inflated outside the patient to check for rupture, and the balloon could not be inflated.The patient tolerated the procedure and no consequences to the patient were reported.

Manufacturer Narrative

Revised c1.Revised h10 - cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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: 13826653
• MDR Text Key: 289080206
• Report Number: 2017233-2022-02812
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA073902J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male