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

Model Number	BXA085902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12591764
• Report Number: 2017233-2021-02449
• Device Sequence Number: 14450874
• Product Code: PRL
• UDI-Device Identifier: 00733132637331
• UDI-Public: 00733132637331
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 06/14/2024
• Device Model Number: BXA085902A
• Device Catalogue Number: BXA085902A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female