(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported difficulties of the device damaged by another device, stent damage and subsequent treatment appear to be related to circumstances of the procedure as major surgery was required to remove the bunched and mangled stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a lesion located in the right iliac artery.The 6.0/39 mm/135 cm otw omnilink stent was advanced and deployed without issue in the lesion, after which an atherectomy device was advanced through the deployed stent in the iliac to perform atherectomy; however, the burr on the atherectomy device broke off leaving the wire on the device free to move which resulted in the wire becoming entangled in the deployed stent and upon removal of the atherectomy device, it pulled the deployed stent, bunched up, into the common femoral artery.The patient underwent surgery for removal of the bunched up stent implant and the atherectomy device.No additional information was provided.
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