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

Catalog Number	BXA075902A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
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 c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H6: code b20: device remains implanted, and no images were provided; therefore, direct product analysis was not possible.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
A study alert from the pivotal aaa 17-01 (tambe) clinical study was received: on (b)(6) 2022, a tambe procedure was performed and the study patient was implanted with several gore® excluder® devices and a gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).Gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were used as branch devices in the visceral arteries.Two or more vbx devices were implanted the superior mesenteric artery (sma), left renal artery, right renal artery, and one vbx device in celiac artery.On (b)(6) 2024, the patient was reported to be in a local hospital with renal failure and is on dialysis.No intervention was reported involving the study device.As stated, patient records were requested.Updated information states a non-contrast ct scan that was done at an outside hospital but they could not determine anything about the renal stents from that scan.The physician did not want to give patient contrast for the ct scan due to the renal failure.Ultrasound was suggested, but no further information at this time.Five vbx devices were implanted.25743768 right renal artery first distal extension.25869696 right renal artery most proximal within the portal.25743769 left renal artery first distal extension.25841797 left renal artery second distal extension.25926891 left renal artery most proximal within the portal.On (b)(6) 2025, patient had right and left renal artery occlusion.Reportedly all five vbx devices occluded.The patient passed away on (b)(6) 2025, due to cardiorespiratory arrest.Per the attending physician, the death was not associated with the gore devices.

• 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: jazmin dela rosa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23292575
• Report Number: 2017233-2025-06700
• Device Sequence Number: 16000715
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: (01)00733132637294(17)251002
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2025
• Device Catalogue Number: BXA075902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 69 KG