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

Model Number BXA085902A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) 2021, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device was intended for use in the right common iliac artery.The physician got left common femoral artery (lcf) access attempting stent placement in the right (rt) common iliac, up and over the aortic bifurcation through a 7fr x 45cm terumo sheath over a 0.035" rosen wire.The patient had severely calcified vessels so the introducer sheath came back as he was trying to push stent over the aortic bifurcation.When he tried to adjust the introducer sheath, the vbx device caught on the sheath tip and dislodged from the balloon.The vbx device stayed on wire and he was able to pull the stent down to the left common femoral (lcf) where he elected to do an open cutdown on the lcf and successfully retrieved the vbx device.Stenting the rt common iliac was aborted and scheduled for the following day.The following day, a vbx device was successfully delivered with no incident.

Manufacturer Narrative

Additional manufacturer narrative: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The device was discarded at the facility.Consequently, a direct product analysis was not possible.H6 - component code, 515 (stent) added.H6 - investigation findings, 213 (no device problem found) updated.H6 - investigation findings, 3221 (no findings available) updated.H6 - investigation conclusions, 4315 (cause not established) updated.Corrected data: h6 - type of investigation, 4115 (device discarded) corrected.

• 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: 12591764
• MDR Text Key: 275478509
• Report Number: 2017233-2021-02449
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637331
• UDI-Public: 00733132637331
• 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: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BXA085902A
• Device Catalogue Number: BXA085902A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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 Sex: Female