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	Partial Blockage (1065)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is unknown which device(s) may have contributed to the stenosis, one additional gore® viabahn® vbx balloon expandable endoprosthesis has been included in this report: lot number: 22340866.Udi: (b)(4).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 following information was reported to gore: on (b)(6) 2020 a patient underwent endovascular treatment of an aortic aneurysm in part with gore® viabahn® vbx balloon expandable endoprostheses (vbx).The vbx devices were utilized in both renal arteries.On (b)(6) 2021, the left renal artery was found to be stenosed.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.A review of the sterilization records indicate the lot met all pre-release specifications.
Additional Manufacturer Narrative
It is unknown which device(s) was involved in the reported stenosis.One additional gore® viabahn® vbx balloon expandable endoprosthesis was implanted during same procedure (implanted left renal artery as overlap) has been included in this report: lot number: 22340866; udi: (b)(4).Review of device manufacturing and sterilization record history confirmed both devices met pre-release specifications.B5, b6 and b7 were updated.H6 component code - selection was made.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient underwent endovascular treatment of an aortic aneurysm in part with gore® viabahn® vbx balloon expandable endoprostheses (vbx).The vbx devices were utilized in both renal arteries.On (b)(6) 2021, the left renal artery was found to be stenosed.No intervention was reported.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11837818
• Report Number: 2017233-2021-02013
• Device Sequence Number: 3508579
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 07/28/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/29/2021; 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 94 KG