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It was reported by the hospital contact that a 5mm micrusphere coil (sph10050020/f72275) prolapsed out of neck into parent vessel and the aneurysm was unable to be reaccessed again through enterprise stent (enf452800/10233431) strut.A 5mm micrusphere coil (sph10050020/f72275) advanced into aneurysm and several loops stayed in but then prolapsed out of neck into parent vessel, after a few attempts with same result the coil was withdrawn and attempt to resheath was unsuccessful due to resheathing problem.Wire and introducer did not rejoin upon zipping back resheathing tool on delivery system.There were no damages noted on the coil after use.Coil was set aside and decision to place stent was made.Enterprise (enf452800/10233431) no tip placed at aneurysm neck and echelon 10 microcatheter (details unknown) was readvanced through the stent into aneurysm.This time a 4mm micrusphere (sph10040020/c23043) was advanced through echelon 10 and upon entering aneurysm it kicked out microcatheter.The coil was removed and resheathed successfully.Wire advanced back into echelon and after multiple attempts he was not able to reaccess aneurysm again through stent strut.The wire would go but the catheter would not.He did not want to move fresh stent.Decision was made to stop the procedure and let heal and come back and try again at a later date.The complaint is for the 5mm micrusphere that did not resheath correctly although technique looked good.The 5mm coil and echelon 10 from the case will be sent in.6fr envoy (details unknown) to lica, echelon 10 to ophthalmic aneurysm.Patient death or serious injury was not alleged as a result of the event.Additional medical intervention or medication was not required to prevent impairment or injury.Patient condition is fine post-op.The procedure was for an ophthalmic aneurysm.No delay in procedure.
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It was reported by the hospital contact that a 5mm micrusphere coil (sph10050020/f72275) prolapsed out of neck into parent vessel and the aneurysm was unable to be reaccessed again through enterprise stent (enf452800/10233431) strut.A 5mm micrusphere coil (sph10050020/f72275) advanced into aneurysm and several loops stayed in but then prolapsed out of neck into parent vessel, after a few attempts with same result the coil was withdrawn and attempt to resheath was unsuccessful due to resheathing problem.Wire and introducer did not rejoin upon zipping back resheathing tool on delivery system.There were no damages noted on the coil after use.Coil was set aside and decision to place stent was made.Enterprise (enf452800/10233431) no tip placed at aneurysm neck and echelon 10 microcatheter (details unknown) was readvanced through the stent into aneurysm.This time a 4mm micrusphere (sph10040020/c23043) was advanced through echelon 10 and upon entering aneurysm it kicked out microcatheter.The coil was removed and resheathed successfully.Wire advanced back into echelon and after multiple attempts he was not able to reaccess aneurysm again through stent strut.The wire would go but the catheter would not.He did not want to move fresh stent.Decision was made to stop the procedure and let heal and come back and try again at a later date.The complaint is for the 5mm micrusphere that did not resheath correctly although technique looked good.The 5mm coil and echelon 10 from the case will be sent in.6fr envoy (details unknown) to lica, echelon 10 to ophthalmic aneurysm.Patient death or serious injury was not alleged as a result of the event.Additional medical intervention or medication was not required to prevent impairment or injury.Patient condition is fine post-op.The procedure was for an ophthalmic aneurysm.No delay in procedure.Visual: limited information was received.The echelon 10 microcatheter was returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was further manipulated and/or inspected post-procedurally.Any trace evidence that may have been complaint related may have been altered or removed prior to being returned.As viewed through the returned packaging, it was found that the coil was unsheathed and damaged.The proximal section has lost its secondary winding shape.Located 14.0 cm off the distal tip of the green introducer, the core wire protrudes outside the sheath for the remainder of its length.Microscopic: there is no mechanical sheath damage at the core wires protrusion site.Socket ring junction.Proximal section of the coil that lost its secondary winding shape.The distal section has retained its secondary shaping.Ball tip.No manufacturing defects were found.The returned undamaged echelon 10 microcatheter was inspected and did not contribute to the coils prolapse out of the aneurysm or to the resheathing difficulty.Summary: as viewed through the returned packaging, it was found that the coil was unsheathed and damaged.The proximal section has lost its secondary winding shape.Due to post-procedural cleaning, handling, and packaging, it cannot be determined how much of the coils damage occurred during the procedure.Located 14.0 centimeters off the distal tip of the green introducer, the core wire protrudes outside the sheath for the remainder of its length.There is no mechanical sheath damage at the core wires protrusion site.The distal section has retained its secondary shaping.No manufacturing defects were found.The exact circumstances of how the coil prolapsed out of the aneurysm cannot be determined, in part, because the aneurysm dimensions are unknown and limited information was received.The exact contributing factor to the coils resheathing difficulty cannot be determined as no damage was found, however, the contributing factor may have occurred if the coil was being resheathed in a manner different than the one outlined by the ifu.If this did occur then for optimum product performance and to prevent potential complications, the ifu recommends, ¿when necessary, the micrus microcoil system can be reloaded into the introducer sheath using the re sheathing tool.Loosen the rhv.Using the fluoroscopic guidance, retract the microcoil from the aneurysm back into the microcatheter.Locate the introducer tip.Grasp the introducer tip with your left hand and the resheathing tool with your right hand.Pull with your right hand while holding on the resheathing tool towards the connector.This will start the resheathing of the coil and the dpu pusher wire.When the resheathing tool reaches the end of the introducer sheath, replace the introducer tip back inside the rhv.Tighten the rhv.With your right hand, grasp the connector and continue to pull the dpu wire out of the sheath until coil is completely inside the distal end of the introducer tip.Loosen the rhv and remove the introducer.Pulling back the dpu wire hub connector¿¿ the damages found during analysis on the device may have occurred during shipping, because it was noted that the device was not damaged after the event.Based on the information and the analysis, the event could not be confirmed, however procedural factors may have contributed to the event.Additionally, a review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.This is an initial/final report.This is 1 of 2 reports associated with (b)(4).For section d 11.Concomitant medical products and therapy dates: enterprise (enf452800/10233431), echelon 10 microcatheter (details unknown), micrusphere (sph10040020/c23043), 6fr envoy (details unknown).
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