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

Model Number	BXAL085901A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
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.Patient age/dob, weight and relevant medical history were requested, but not made available.Review of device manufacturing record history confirmed device met pre-release specifications.The dislodged device remains implanted; the balloon catheter was discarded at user facility.Therefore, direct product analysis was not possible.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis state in warnings section: do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, a patient presented with an iliac artery occlusion.As reported, the artery was tortuous and heavily calcified.From the common femoral access, an 8fr cordis brite tip® sheath was placed and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was advanced to the intended treatment site.Before attempting to deploy the vbx device, the physician decided to do another angiogram as the vbx device appeared too short.The vbx device was attempted to be pulled back through the sheath after it was fully introduced into vessel.Reportedly, pressure was experienced as the device was pulled.The vbx stent was caught on calcification.Dislodging it from the balloon catheter.A new vbx device was used to pin the constrained vbx stent against the iliac vessel wall.Good blood flow was re-established to the patient's foot.The patient was reported to be doing well following the procedure.
Additional Manufacturer Narrative
Device remains implanted; delivery catheter and deployment line were discarded at user facility.An engineering evaluation was completed.The cause of the reported device dislocation could not be established with the information provided.However, the complaint description does state the vbx device caught on calcification, dislodging the endoprosthesis from the delivery catheter.
Additional Manufacturer Narrative
Conclusion code 4311 was removed.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12625498
• Report Number: 2017233-2021-02468
• Device Sequence Number: 14308078
• Product Code: PRL
• UDI-Device Identifier: 00733132637836
• UDI-Public: 00733132637836
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: BXAL085901A
• Device Catalogue Number: BXAL085901A
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 03/02/2022; 05/05/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 03/08/2022; 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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
• Patient Sex: Male