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	Complete Blockage (1094)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Renal Impairment (4499)
Date of Event	08/24/2022
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.F28: acute kidney injury necessitating ongoing dialysis.During implant procedure two gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) as branch device components in the renal artery.The vbx devices were overlapped and deployed as one unit in the same anatomical location.Report did not specify if one or both devices occluded.The second implanted vbx device is lot/serial (b)(6); udi (b)(6).H6 - code c19: review of device manufacturing record history confirmed both vbx devices met pre-release specifications.H6 - code b20: both vbx devices remain implanted and no images were provided; therefore, direct product analysis was not possible.The ifu was reviewed and the following statement was found to be applicable: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion.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 or Problem Description
The following was reported to gore from a study: on (b)(6) 2020, the study patient was treated for aortic aneurysm.As a staged procedure, a conformable gore® tag® thoracic endoprosthesis was implanted.A gore® excluder® thoracoabdominal branch endoprosthesis (tambe device) was implanted with gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) as branch device components.On (b)(6) 2022, the patient presented to hospital with acute kidney injury from the left renal artery occlusion.This adverse event led to acute renal failure.On the same date, right renal artery occlusion was also reported.On (b)(6) 2022, the patient began in-patient hemodialysis and it was stopped on (b)(6) 2022.Exact start date of outpatient dialysis is unknown; however, patient stated ongoing outpatient dialysis is done each week (mondays, wednesdays, and fridays).

• 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: 19464110
• Report Number: 2017233-2024-05014
• Device Sequence Number: 12730380
• Product Code: PRL
• UDI-Device Identifier: 00733132637294
• UDI-Public: 00733132637294
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 05/15/2023
• 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: 05/14/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2020
• 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
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White