(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual inspection was performed on the returned device.The stent damage was confirmed.It is likely that the omnilink elite was not properly aligned during insertion into the sheath causing the stent damage.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported revealed no other incidents.The investigation determined that the reported difficulties were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat an 80% stenosed and heavily calcified lesion in the iliac artery.It was noticed that the stent of a 6x29mm omni elite unraveled (flared) while attempting to insert it into the sheath.It was confirmed that the stent did not dislodge; however, the specific stent damage could not be confirmed.The procedure was successfully completed with a new omni elite stent.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.The return device analysis found that the stent was stretched out and dislocated on the balloon yet stationary, with the proximal end of stent at 12.5mm proximal to distal balloon marker.
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