Review of device manufacturing record history confirmed device met pre-release specifications.The device was discarded at user facility.Therefore, direct product analysis was not possible.Instructions for use (ifu) for gore® viabahn® endoprosthesis with heparin bioactive surface states: contraindications: the gore® viabahn® endoprosthesis is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
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The following was reported to gore: patient was treated due to an occluded superficial femoral artery (sfa).As reported, this patient had previous surgeries and access from the femoral artery was no longer an option.Pedal approach, with access from the anterior tibial artery was made.After access was obtained, multiple balloon catheters including a 5x15 sterling and 3x200 mustang were used for vessel dilation.A 6fr terumo sheath was then used to advance a 6x15 gore® viabahn® endoprosthesis over a platinum plus wire.As the viabahn device was advanced, it became stuck within the sheath.The physician attempted to pull the device back out.As the viabahn device was manipulated, the wire inside the catheter was broken.The deployment line at the transition was severed.The patient was transferred for surgical repair.The tibial artery was cut down to allow for the constrained viabahn device and sheath to be removed.After the artery was repaired, a second access was made at the popliteal artery, located behind the knee.Wire access was achieved, and two viabahn devices (6x25 and 5x15) were deployed to treat the occlusion in the sfa.Post procedure, the patient was reported to be recovering with pulse (signal) to the foot.
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