The following was reported to gore: on (b)(6) 2021, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device was intended for use in the iliac artery.During the advancement of the vbx device, the physician was met with resistance in the calcified lesion.When the physician attempted to remove the vbx device, it had become dislodged in the calcification.The decision was made treat the patient with open procedure.The physician didn't feel this was a good place leave the vbx device and removed it with a snare.The patient did not experience any adverse consequences.
|
Section h6 updated to reflect completion of investigation.Review of device manufacturing record history confirmed device met pre-release specifications.Engineering evaluation was completed with the following information.It was reported that a gore® viabahn® vbx balloon expandable endoprosthesis device met resistance, was unable to reach target location and the endoprosthesis became dislodged.The vbx device was returned with the endoprosthesis separated from the delivery system.The stent rings of the endoprosthesis were compressed longitudinally, overlapping, and nesting together.Bent and delaminated rings were also observed.The cause of failure to advance, and the associated stent dislodgement, could not be confirmed by the device evaluation.However, the complaint description states, when the physician attempted to remove the vbx device, it had become dislodged in the calcification.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements in the directions for use, treatment of vessel section: percutaneous transluminal angioplasty (pta).It is recommended to pre-dilate the lesion to allow for easy passage of the gore®viabahn® vbx balloon expandable endoprosthesis.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.
|