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

Model Number	BXA112902A
Medical Device Problem Codes	Inflation Problem (1310); Malposition of Device (2616); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2022, a patient underwent treatment for the right common femoral artery utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device during a transcatheter aortic valve replacement (tavr) procedure.It was reported that the technician prepared the device with a short, negative pressure on the balloon and then the vbx device was advanced to the right common femoral artery from the contra-lateral side using an 8 fr ansel sheath.The physician reported that the vbx device was difficult to advance through the sheath, although it was ultimately able to be advanced to the intended location.Upon inflation, the balloon on the stent reportedly inflated on the proximal end, but not the distal end.The stent then dislodged from the balloon catheter with enough force to push it into the distal third of the superficial femoral artery (sfa).An attempt was made to use a separate balloon (armada 14mm x 20mm), but the stent was unable to be fully deployed.The patient was the taken to surgery and an open cut-down was performed to fix the leak in the common femoral artery.A sheath and guidewire were then used to access the stent in the sfa, and a 6mm armada balloon was used to successfully deploy the stent in the sfa.The patient tolerated the procedure and is reported to be recovering well.
Additional 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.
Additional Manufacturer Narrative
The manufacturing records were reviewed and the device lot met all pre-release specifications.The device remains implanted, therefore direct product evaluation was not possible.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14310177
• Report Number: 2017233-2022-02906
• Device Sequence Number: 14770772
• Product Code: PRL
• UDI-Device Identifier: 00733132637706
• UDI-Public: 00733132637706
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2024
• Device Model Number: BXA112902A
• Device Catalogue Number: BXA112902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male