(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other similar incidents reported from this lot.The investigation determined that the reported difficulties were due to case circumstances.The absolute pro caused damage to the previously implanted supera stent while attempting to advance through.As a result, the absolute pro stent was also stretched at the location where it overlaps the supera stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The supera device referenced is being filed under separate medwatch report.
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It was reported that the procedure was performed to treat a calcified lesion in the superficial femoral artery.A 5.5x150mm supera self-expanding stent was deployed without issue.A 7.0x100mm absolute pro self-expanding stent system (sess) was advanced through the implanted supera stent; however, the absolute pro sess grabbed the deployed supera stent while advancing and stretched the stent to the length of the sfa.The absolute pro stent was deployed at the intended location; however, since the supera stent had been stretched for the length of the sfa the absolute pro stent was overlapping the supera stent.The absolute pro stent is also stretched at the location where it overlaps the supera stent.There were no issues deploying either of the sess and both stents were apposed in non-healthy tissue.There were no issues during removal of the delivery systems.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
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