It was reported that the procedure was performed to treat a lesion in the right coronary artery.A 4x15mm xience xpedition stent delivery system (sds) was advanced against resistance with the anatomy, and contrast was noted to be leaking from the balloon during inflation.The stent was implanted in the intended site, and the same sds balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The device was returned for analysis.The reported material rupture was able to be confirmed.The reported difficult to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the calcified anatomy resulted in the reported difficulty to advance.Interaction with the calcified anatomy and/or manipulation of the device resulted in compromising the balloon; thus resulting in the reported material rupture/noted balloon pinhole as the balloon was attempted to be inflated.The observed tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire.This type of mechanical damage can occur if an attempt is made to pull the stent delivery system in an opposite direction as the guide wire.Reportedly, the 4x15mm xience xpedition stent delivery system (sds) was advanced against resistance with the anatomy and contrast was noted to be leaking from the balloon during inflation.The stent was implanted in the intended site, and the same sds balloon was used to successfully complete the procedure.It should be noted that the xience xpedition instructions for use states: prior to using the xience xpedition, xience xpedition sv, and xience xpedition ll everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.As the reported material rupture/noted pinhole was noted during inflation of the balloon during stent deployment, continuing the procedure to deploy the stent seemed to be an appropriate response/action.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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