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

Catalog Number BXA117902B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Aneurysm (1708)

Event Date 01/24/2022

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2022, a gore® viabahn® vbx balloon expandable endoprosthesis was intended for use in a covered endovascular reconstruction of the aortic bifurcation (cerab) procedure.A begraft aortic device was used for aortic component (2x 16mm x 48mm, 11fr, dilated to 18mm on same balloon as stent grafts were mounted), 2 gore® viabahn® vbx balloon expandable endoprosthesis were planned for bilateral kissing stents into begraft aortic.12fr dsf used on right side which delivered begrafts successfully.An 8fr cordis brite tip sheath used on left side (2.7mm id).2x 300cm supracore wires were used.Cutdown access was gained, as patient had bilateral endarterectomies amongst other surgical procedures.Gore® viabahn® vbx balloon expandable endoprosthesis device(s) were prepared correctly as per ifu and were covered and held with gauze as both were put on wires and then into sheaths.Both stents were then advanced out of the sheaths, in the cia ready to be put into final position before deployment.Surgeon realized that the left wire had been jailed to the aortic wall.He decided to retract the stent back into the sheath and felt resistance.As the surgeon pulled past the resistance, the field sales associate (fsa) reportedly stated: to stop as the stent seems to be coming off of the balloon.He had already pulled too far and had assured the fsa that the stent was captured inside the 8fr brite tip.The whole system was removed (excluding wire) and it was noted that the stent wasn't observed to have been removed.An angiogram was performed, and was confirmed to still be in the patient, undeployed.Since the patient already had cut down access, the surgeon decided that he would try and retrieve the gore® viabahn® vbx balloon expandable endoprosthesis surgically.After approximately 10 minutes, he was unsuccessful.An open procedure was performed to remove the gore® viabahn® vbx balloon expandable endoprosthesis and an aorto-biffem graft was successfully implanted to complete the procedure.The patient did not experience any adverse consequences.

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.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The device was discarded at the facility.Consequently, a direct product analysis was not possible.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), 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.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13416833
• MDR Text Key: 291483401
• Report Number: 2017233-2022-02706
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA117902B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2021
• 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 Age: 68 YR
• Patient Sex: Male