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

Catalog Number BXA075902E

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

Patient Problems Renal Failure (2041); Stenosis (2263)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.Therefore no engineering evaluation could be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2019, the patient underwent an endovascular aortic repair (chevar) due to an abdominal aortic aneurysm.As the main body an endurant ii stent graft system (medtronic) was used.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used as a snorkel/chimney to treat the pararenal aneurysm of the right renal artery.A brachial percutaneous access was gained by cut.The study database indicates that the device was successfully placed and deployed as intended without abnormalities noticed.The device was patent at the end of the procedure.On (b)(6) 2020, an occlusion of the vbx device occurred.The study database indicated a permanent impairment of right renal function and advanced hepatocellular carcinoma.Therefore, no reintervention was performed, and no hospitalization was required.

Manufacturer Narrative

H6-code 213: a review of the manufacturing records indicated the lot met all pre-release specifications.

• 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: 10411058
• MDR Text Key: 203480114
• Report Number: 2017233-2020-01133
• Device Sequence Number: 1
• Product Code: PRL
• 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
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Catalogue Number: BXA075902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDURANT II STENT GRAFT SYSTEM (MEDTRONIC).
• Patient Outcome(s): Disability
• Patient Age: 76 YR
• Patient Weight: 68