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

Catalog Number	BXA115901A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 - code a27: per physician, the vbx balloon was ruptured, likely due to calcified plaque that was in treatment area.A non-gore balloon was used to achieve optimal expansion of the implanted vbx stent.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b01: device was returned 3/30/2026.Results pending completion of investigation.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr 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 or Problem Description
The following was reported to gore: during treatment in an infra-renal aorta, a 12 x 30 mm shockwave was used.Next, an 11 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was deployed about 1 cm proximal to aortic bifurcation.This was confirmed with ivus.It was reported the vbx stent was deployed in a calcified aorta.During deployment, the vbx device was initially inflated to 6atm due to closeness of the aortic bifurcation.The balloon was then advanced 1cm proximal to distal edge of the vbx stent and taken to nominal pressure of 10 at which point the balloon ruptured.The ruptured balloon was removed from the patient with no issues.The vbx stent was post dilated with a 14x20mm abbott armada balloon.Optimum result was achieved.The patient did not experience any adverse consequences.The physician stated the issue was likely due to the calcified plaque.
Additional Manufacturer Narrative
With the completion of investigation, this report is retracted as the balloon was found to be intact.Additional information received from the field stated 'there was blood in the inflation device line, and it had been concluded the balloon ruptured.D8/d9 - fields were updated as device was returned.Engineering evaluation results state: the primary reported failure mode of balloon burst was not confirmed by the engineering evaluation.The engineers observed dried blood and contrast in the guidewire lumen and were unable to flush the guidewire lumen.Aspiration at the inflation port was successful with no observations of air bubbles or pressure loss which could indicate a leak.The device was successfully inflated to nominal inflation pressure of 10atm and held pressure with a cylindrical appearance of the balloon covered end of catheter.The cause of the reported failure mode could not be established with the available information or evaluation.It was reported that ¿the vbx device was initially inflated to 6atm due to closeness of the aortic bifurcation.The balloon was then advanced 1cm proximal to distal edge of the vbx stent and taken to nominal pressure¿.The vbx device instructions for use (ifu) warns ¿do not attempt to withdraw or reposition the balloon catheter within the lumen of the deployed endoprosthesis unless the balloon is completely deflated.¿ the ifu also instructs ¿do not deploy the endoprosthesis unless it is properly centered on the balloon and properly positioned within the target lesion.¿ these use errors did not contribute to the reported failure mode as no balloon burst was confirmed.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24760889
• Report Number: 2017233-2026-07323
• Device Sequence Number: 18431444
• Product Code: PRL
• UDI-Device Identifier: 00733132637737
• UDI-Public: (01)00733132637737(17)290106
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: BXA115901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female