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

Model Number BXA057902A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10608257
• MDR Text Key: 209359911
• Report Number: 2017233-2020-01311
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637454
• UDI-Public: 00733132637454
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: BXA057902A
• Device Catalogue Number: BXA057902A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 83 YR
• Patient Weight: 94