The device was not returned for evaluation.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that during treatment of an aneurysm located in the internal carotid artery (ica), the physician prepared to release the device, but it was found the "head" of the device could not be opened.It was reported that the physician made numerous maneuvers without success.A new pipeline device was used to complete the surgery.No patient injury was reported.The aneurysm max diameter was 18mmx25mm.The distal landing zone was 3.1 mm and the proximal was 4.07 mm.
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The pipeline pushwire was returned for evaluation.The pipeline braid was not returned for evaluation.The pushwire was observed to be bent within the capture coil.Pushwire kink was also observed at 2.0cm and 2.3cm from the distal tip coil.No other anomalies were observed.Based on the analysis findings and the reported event details, the clinical observation was not confirmed.We are unable to definitively determine the cause for the reported experience as the pipeline braid was not returned; therefore, any contributing factors from the pipeline braid could not be assessed.Additionally, the patient¿s vessel tortuosity was not reported; therefore any contributing factors from the patient¿s vessel tortuosity could not be assessed.It is possible that the ¿pushwire bend within the capture coil¿ and the pushwire kinks may have contributed to the reported experience.However, the cause for the damages could not be determined.Per our instructions for use (ifu): ¿detachment can be facilitated by slowly rotating the delivery wire in the clockwise direction and/or manipulating the microcatheter by locking down the delivery wire and moving both as a system.If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered ped, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire.¿ additionally, the lot history record review showed no discrepancies that would have contributed to the reported experience.All products are 100% inspected for damage and irregularities during manufacture.
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