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

Model Number	BXAL085902A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: patient presented for treatment in the left leg due to an observed leak after placement of a gore® excluder® aaa endoprosthesis.As reported, the patient's anatomy was very tortuous and the target treatment area was stenotic and aneurysmal.A gore® excluder® iliac branch endoprosthesis (ibe device) was deployed in the internal iliac artery.A 10mm x 65mm gore® dryseal flex introducer sheath (dryseal sheath) was used to advance gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Although difficulty was experienced during advancement through the dryseal sheath, one vbx device was placed and deployed.Next, an 8lmm x 59mm vbx device was to be advanced.However, the ibe device and the first deployed vbx device reportedly interfered with advancement of the 8lmm x 59mm vbx device.At this time, the vbx stent came off the delivery catheter.The dislodged stent and sheath were removed together with no issues.Coiling was performed instead of attempting to place additional devices.The patient did not experience any adverse consequences.The devices not implanted were discarded at user facility.
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.Review of device manufacturing record history confirmed device met pre-release specifications.The device was not returned to gore.Therefore, direct product analysis was not possible.Patient's weight, medical history and medications were requested but not made available.

• 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: 13509463
• Report Number: 2017233-2022-02733
• Device Sequence Number: 14731371
• Product Code: PRL
• UDI-Device Identifier: 00733132637669
• UDI-Public: 00733132637669
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 02/18/2024
• Device Model Number: BXAL085902A
• Device Catalogue Number: BXAL085902A
• 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: 01/26/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male