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

Model Number BXA077902A

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/25/2022

Event Type  Injury  

Event Description

The following ae was received from medrio.Subject: (b)(6).Site: (b)(6).Form: form 22 - adverse event, visit: adverse event - 01, ae: occluded right renal artery.Ae onset: (b)(6) 2022.Two vbx devices are in the patient's right renal artery.It was noted that treatment is/was required.Date of procedure/implant was (b)(6) 2022.

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.Due to no device return, an investigation could not be performed.Information in regards to which device that was implanted within the right renal artery occluded was not available.Analysis of the manufacturing records for both devices lot/serial # (b)(4) and lot/serial # (b)(4) are the following: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.

Event Description

On (b)(6) 2022, a patient received a procedure to treat a thoracoabdominal aortic aneurysm with the gore® viabahn® vbx balloon expandable endoprosthesis being implant in the right renal artery.On (b)(6) 2022, it was noted that there was an occlusion within the right renal artery stent.On (b)(6) 2022, the patient received an reintervention to the right renal artery.The right renal artery had suction thrombectomy and stenting.Patient tolerated procedure.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14776864
• MDR Text Key: 294544438
• Report Number: 2017233-2022-03034
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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
• Device Operator: Health Professional
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White