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

Catalog Number	BXB065902A
Medical Device Problem Codes	Obstruction of Flow (2423); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Renal Impairment (4499)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent an endovascular tambe procedure in zone 5 descending aorta to treat a juxtarenal aneurysm utilizing a gore® excluder® thoracoabdominal branch endoprosthesis.As branch devices, gore® viabahn® vbx balloon expandable endoprosthesis were implanted in the visceral arteries.Two vbx devices were implanted (overlapped) in the left renal artery.On august 06, 2024, the field sales associate (fsa) was notified by the physician that the left renal portal of tambe device has thrombosed along with the two gore® viabahn® vbx balloon expandable endoprosthesis and leading to the occlusion of the patient's left renal artery.Reportedly, this was a known probability due to the anatomy of the aneurysm as patient's anatomy was challenging and torturous.The occlusion was found during a post-op ct scan that was done prior to discharge from hospitalization (date unknown).The physician is going to get a follow up ct scan done in 6 months.No intervention is planned at this time and patient is doing fine but has lost left kidney function.No dialysis appears to be needed at this time.Vbx device failure mode code 2203-a:-other (left kidney function loss).
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.A4: patient weight was requested but not made available.B7: patient medical history and medication information were requested but not made available.Two vbx devices were implanted in an overlapped fashion to extend into the patient's left renal artery during implant procedure.It is unspecified if one or both devices occluded.The second device information is: lot/serial # (b)(6); catalog # bxb065902a; udi # (b)(4).B20: both devices remain implanted and no images were provided; therefore, direct product analysis was not possible.C19: review of device manufacturing record history confirmed both devices met pre-release specifications.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: on (b)(6) 2024, the patient underwent an endovascular tambe procedure in zone 5 descending aorta to treat a juxtarenal aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis.As branch devices, gore® viabahn® vbx balloon expandable endoprosthesis were implanted in the visceral arteries.Two vbx devices were implanted in an overlapped fashion in the left renal artery.On (b)(6) 2024, the physician reported the left renal portal of tambe device has thrombosed along with the two gore® viabahn® vbx balloon expandable endoprosthesis and leading to the occlusion of the patient's left renal artery.Reportedly, this was a known probability due to the anatomy of the aneurysm as patient's anatomy was challenging and torturous.The occlusion was found during a post-op ct scan that was done prior to discharge from hospitalization (date unknown).The physician is going to get a follow up ct scan done in 6 months.No intervention is planned at this time and patient is doing fine but has lost the left kidney function.No dialysis appears to be needed at this time.
Additional Manufacturer Narrative
B5 - description summary was updated.
Additional Manufacturer Narrative
H6 - code d1001: ae was related to patient condition due to the physician's comments about the challenging anatomy leading to the event.

• 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: 20140950
• Report Number: 2017233-2024-05284
• Device Sequence Number: 7482407
• Product Code: PRL
• UDI-Device Identifier: 00733132658466
• UDI-Public: 00733132658466
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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 Catalogue Number: BXB065902A
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/27/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/04/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Female