The device was returned for analysis.The reported patient-device incompatibility-wall apposition and the reported migration-stent were unable to be replicated in a testing environment as it was based on operational circumstances.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 incidents from this lot.The reported patient effect of thrombosis is listed in the supera peripheral stent system instructions for use (ifu) as potential adverse effects of peripheral percutaneous intervention.It is possible that during initial deployment the diameter of the stent used was inadvertently undersized for the size of the vessel; thus resulting in the reported patient-device incompatibility wall apposition and ultimately resulted in the reported stent migration; however this cannot be confirmed.The investigation determined a conclusive cause for the reported patient-device incompatibility wall apposition and the reported stent migration cannot be determined.As there was no damage noted to the device during the inspection prior to use, it is likely that inadvertent mishandling resulted in the noted device damages (pinched sheath, separated tip jacket/inner member).The reported difficulties possibly caused/contributed to the reported patient effects; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|