The device was not returned 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 from this lot.The investigation was unable to determine a conclusive cause for the reported stent shortening.Based on the information reviewed, 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 performed to treat a 90% stenosed, mildly tortuous, and heavily calcified lesion in the distal superficial femoral artery.The 5.0mm vessel was prepared with a 5.5mm armada 18 balloon catheter at rated pressure for one minute.A 5.5x120mm supera self-expanding stent was deployed as per normal; however, the stent compressed/shortened greater than 10% from it's intended length.The stent remained within the intended site.The procedure was successfully completed with a new 5.5x200mm supera stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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