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

Model Number BXAL083902A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2022

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2022, an endovascular treatment was performed in the patient's left common iliac artery due to bilateral iliac calcification and peripheral artery disease.A 7fr terumo pinnacle sheath was used to advance an 8mm x 39mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) over a.035 glidewire advantage.When the vbx device reached the intended treatment site, it was realized the device was too long.The physician opted to remove the vbx device.However, as the vbx device was pulled back, the vbx stent dislodged from the balloon catheter in the left external iliac artery.A groin cutdown was performed to retrieve the dislodged vbx stent via an arteriotomy in the left femoral artery.The intact stent was retrieved and the artery was closed.The patient tolerated the procedure.

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.Other relevant history: information on patient relevant medical history and medications were requested, but not made available.(b)(4).Ifu for gore® viabahn® vbx balloon expandable endoprosthesis warnings section state: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.

Manufacturer Narrative

H6: code 213: engineering evaluation states no further information could be obtained concerning whether native vessel dimensions were accurately measured prior to device introduction.The reported failure mode, endoprosthesis loses retention to delivery system corresponding to the secondary hazardous situation (i.E., embolization), could not be independently confirmed during evaluation of the device.The root cause is consistent with reasonably foreseeable misuse in the reported attempt to remove the delivery system with the stent still mounted through the sheath leading to the potential for stent migration.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis warnings section states: 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.

Manufacturer Narrative

B1: adverse event and reportable malfunction were both selected because intervention was necessary after stent became dislodged from catheter.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14466091
• MDR Text Key: 293628036
• Report Number: 2017233-2022-02950
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637829
• UDI-Public: 00733132637829
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BXAL083902A
• Device Catalogue Number: BXAL083902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 83 KG