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

Model Number	BXA113902A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/29/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Additional manufacturing narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.(b)(4).
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for aortic occlusive disease and was implanted with gore® excluder® conformable aaa endoprostheses.The trunk ipsilateral leg component deployed correctly but was positioned slightly higher than intended with partial coverage of the ostium of a renal artery.The device was reconstrained and the physician attempted to reposition but struggled with trying to reposition the cxt and chose to leave it as is and implant a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) covered stent in one of the renal arteries to ensure good flow.During post-dilitation of the vbx with a coda balloon catheter the renal artery was ruptured due to believed over-inflation of the balloon.The patent expired intra-procedure, a cause of death was not provided.
Additional Manufacturer Narrative
Updated device details.

• 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: 12334566
• Report Number: 2017233-2021-02280
• Device Sequence Number: 14127248
• Product Code: PRL
• UDI-Device Identifier: 00733132637720
• UDI-Public: 00733132637720
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 04/18/2023
• Device Model Number: BXA113902A
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 08/27/2021
• 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: Death; Hospitalization; Other
• Patient Age: 59 YR