(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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It was reported that the procedure was to treat a heavily tortuous and heavily calcified right coronary artery.Two unspecified stents were implanted proximally to the lesion.A 2.5 x 15 mm xience sierra stent delivery system (sds) was advanced through the two unspecified stents but failed to cross the lesion due to the anatomy.The patient experienced bradycardia.During removal of the xience sierra, the stent became caught with one of the implanted stents and dislodged from the stent delivery balloon.The dislodged stent was not noted until the sds was re-inserted inside the anatomy.There was a failed attempt to retrieve the stent into the lesion.The stent became deformed and entangled with one of the implanted stents.The patient was then sent to coronary artery bypass graft surgery; however, the stent remained in the anatomy.No additional information was provided.
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Device codes: 2017 labeled na.Internal file number - (b)(4).Correction: device code 2017 added for use distal to stent.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 did not indicate a lot specific quality issue.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use, states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodge during retraction back into the guiding catheter.It is unknown if the ifu deviations directly caused or contributed to the reported event.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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