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

Catalog Number BXA055902B

Device Problem Material Puncture/Hole (1504)

Patient Problem Aneurysm (1708)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Device lot/serial information could not be obtained.Therefore, no manufacturing evaluation could be performed.The device remains in the patient.Consequently, a direct product analysis was not possible.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following was reported to gore: on an unknown date in 2019, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device was placed in the renal artery as a fenestration device in a cook aaa t branch graft.On (b)(6) 2021, ultrasound analysis indicated the 5mm x 59mm vbx device had a type 3 endo leak on the outside corner of the graft on a 90 degree bend.A successful re-intervention was performed to reline existing vbx device with a 6 mm x 79mm vbx device.The patient did not experience any adverse consequences.

Manufacturer Narrative

Additional manufacturer narrative: h6 - component code 515 (stent) added.H6 - investigation findings, updated with 3221 (no findings available).H6 - investigation conclusions , updated with 4315 (cause not established).Imaging evaluation summary: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.W.L.Gore & associates cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, w.L.Gore & associates cannot guarantee all key findings have been captured or that the findings are accurate.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12704506
• MDR Text Key: 278586922
• Report Number: 2017233-2021-02493
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA055902B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 81 YR
• Patient Sex: Female