The device was not returned for analysis.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that interactions with the moderately calcified and 90% stenosed anatomy and/or a coagulation of blood and contrast on the guide wire resulted in the reported difficult to remove; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional supera device(s) referenced in b5 is/are filed under separate medwatch report number(s).
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It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa) with moderate calcification, no tortuosity and 90% stenosis.A 6.0x150mm 120cm supera self-expanding stent system (sess) was advanced over a non-abbott 0.014 guide wire (gw) to the target site.The supera stent was deployed at the intended site without issue.During withdrawal of the delivery catheter, resistance was felt with the gw, thus both were removed from the anatomy intact as one unit which caused loss of access.A new access site was established, and a second 5.5x150 120cm supera sess was advanced over a new non-abbott 0.014 gw to the intended target site.The stent was deployed without issue.Again during withdrawal, the delivery system felt resistance with the gw and both were removed from the anatomy as one unit, intact.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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