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

Model Number	BXA057902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Renal Failure (2041); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Concomitant medical devices: as it is not known which device if any contributed to the acute kideney injury, the reported device and all of the following were investigated: bxa067902a sn#: (b)(4), udi: (b)(4), bxa057902a sn#: (b)(4) udi: (b)(4), bxa067902a sn#: (b)(4), udi: (b)(4), bxa067902a sn#: (b)(4), udi: (b)(4).(b)(4).A review of the manufacturing records for the devices verified the lots met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient underwent endovascular aortic debranching with investigational tambe devices.Gore® viabahn® vbx balloon expandable endoprostheses were utilized in both renal arteries.On (b)(6) 2020 the patient exhibited acute kidney injury, which was reported to have been possibly device related.The kidney injury was not specified to a certain side, but rather detected as a general finding in a kidney function test.No treatment was rendered and the case is ongoing.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient underwent endovascular aortic debranching with investigational tambe devices.Gore® viabahn® vbx balloon expandable endoprostheses were utilized in both renal arteries.On (b)(6) 2020 the patient exhibited acute kidney injury, which was reported to have been possibly device related.The kidney injury was not specified to a certain side, but rather detected as a general finding in a kidney function test.No treatment was rendered and the case is ongoing.Upon further investigation, the acute kidney injury was not found to be due to any device-related issue.There was no occlusion or stenosis.The renal arteries were patent.
Additional Manufacturer Narrative
B.5.Updated.Medwatch # 2017233-2020-01311 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch (and supplementals) will be retracted.

• 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
• MDR Report Key: 10608257
• Report Number: 2017233-2020-01311
• Device Sequence Number: 2940886
• Product Code: PRL
• UDI-Device Identifier: 00733132637454
• UDI-Public: 00733132637454
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 01/11/2023
• Device Model Number: BXA057902A
• Device Catalogue Number: BXA057902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 83 YR
• Patient Weight: 94