It was reported the procedure was to treat a dissection in the right common iliac artery.The 7.0 x 39 mm x 80 cm omnilink stent failed to cross due to the anatomy.During removal, resistance was felt with the introducer sheath, the stent struts stretched, and the stent moved but remained on the balloon.A new omnilink stent was implanted without further issue.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
|
Visual analysis was performed on the return device.The reported failure to advance and difficulty removing were not confirmed as it was related to procedural conditions.The stent damage and dislodgment were confirmed.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 and/or complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.It is likely that the reported failure to advance was due to interaction with the anatomy.Additionally, after the failed attempt to cross, it is likely that the stent became compromised on the balloon such that during removal, the stent caught on the distal end of the introducer sheath causing further damage to the stent and the stent to dislodge from the original crimped location on the balloon.There is no indication of a product issue with respect to manufacture, design, or labeling.
|