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

Model Number	BXAL087902A
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/04/2021
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.
Event or Problem Description
The clinical specialist reported the following information: the patient underwent endovascular treatment of an internal iliac artery aneurysm using a gore® excluder® iliac branch endoprostheses and two gore® viabahn® vbx balloon expandable endoprosthesis (vbx) (21717425, unk).It was reported that the iliac branch component was successfully placed with no reported issues.When the physician advanced the internal iliac component, it was reported that the device was unable to advance into the patient's internal iliac artery.The undeployed device was removed, and two gore® viabahn® vbx balloon expandable endoprosthesis (vbx) were used in the patient's internal iliac artery.After placement of the vbx devices the physician reported good blood flow through the internal iliac artery.The internal iliac component was reportedly discarded.After placement of the remaining devices, a final angiography was performed and it was reported that the patient's internal iliac artery was occluded.This report is associated with vbx device lot number 21717425.

• 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: 11934947
• Report Number: 2017233-2021-02054
• Device Sequence Number: 4344997
• Product Code: PRL
• UDI-Device Identifier: 00733132637676
• UDI-Public: 00733132637676
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 12/28/2022
• Device Model Number: BXAL087902A
• Device Catalogue Number: BXAL087902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR