The patient was presented with an occluded gore® viabahn® endoprosthesis which was implanted within the right popliteal artery approximately two years ago in another hospital.It was stated that the medical device occlusion was intended to be treated with a gore® tigris® vascular stent.It was reported to gore that the device occlusion was predialated with a 5x150 balloon and that the gore® tigris® vascular stent was inserted through a 6fr introducer sheath and advanced over a 0.035 stiff guidewire by using a cross over approach.It was stated that the patient¿s vessel itself did not indicate any calcification or tortuosity.It was reported to gore that when device deployment was initiated the stent didn¿t continue to deploy completely as the deployment wheel became stuck and couldn¿t be rotated any further.It was stated that the ¿safety catch¿ was even tried to be pulled without any success.It was reported to gore that the physician was able to retrieve the partial deployed tigris device from the patient¿s vessel through the introducer sheath, where a lot of force was required, without performing a conversion of the patient¿s leg.Consequently, as the patient¿s vessel layers were injured, the popliteal artery and superficial femoral artery occluded.A thrombectomy was performed and the lesion was treated by implanting another stent (supera stent).It was stated that the patient is doing well following the procedure and that a good blood flow was established.
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The review of the manufacturing records verified that this lot met all pre-release specifications.When physically evaluated upon return, the following observations were made: the gore® viabahn® endoprosthesis was kinked at multiple locations along the catheter, including near the strain relief.The inner shaft was flattened proximal to features.The tear tube was severed at the thumbwheel.Destructive disassembly of the outer sheath and strain relief was required to remove the tear tube from the outer sheath at the location of the strain relief.Approximately 32.5 mm of the distal end of the stent was uncovered.The coupler bond was unable to be removed without destructive removal of the outer sheath.The coupler bond appeared unremarkable.
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