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

Catalog Number BXA052902E

Device Problem Complete Blockage (1094)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.(b)(4).

Event Description

The patient underwent fenestrated endovascular aortic procedure with 2 gore® viabahn® vbx balloon expandable endoprosthesis which were used for the renal arteries.It was reported that both renal arteries were occluded.Recent details reported that the patient's indication for undergoing fevar is due to aneurysm in the visceral arteries.On (b)(6) 2022, the occlusion was diagnosed and a graft was used to perform a dual bypass surgery from his iliac arteries to his kidneys on (b)(6) 2022.Afterwards, hemorrhage was identified in the right kidney and this lead to removal of the graft.It was reported that the left kidney is still functional and the patient is not on dialysis.The physicians were not able to deduce the reason for the occurrence of the occlusion, the patient was discharged on (b)(6) 2022.

Manufacturer Narrative

1) update investigation findings code.2) update investigation conclusion code.3) please select an appropriate health effect ¿ clinical code.4) please select an appropriate health effect ¿ impact code.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14927152
• MDR Text Key: 295308382
• Report Number: 2017233-2022-03095
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA052902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male