(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was returned.Visual inspections were performed on the returned device.The tip detachment was confirmed.The difficulty removing and resistance was unable to be tested as it was based on circumstances of the procedure.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported the tip detachment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a lesion located in the popliteal that was described as fibro-calcific.After placement of a 6fr x 55 cm sheath, the vessel was prepped per supera instructions for use.Predilatation was performed on the 5 mm vessel with an armada balloon catheter.A 5.5 x 40 supera peripheral self-expanding stent system (sess) was advanced through the sheath against resistance, then to the lesion.The stent was deployed without difficulty and was fully released.The thumbslide was confirmed to be in the locked position and the delivery system was withdrawn with slight resistance felt with the deployed stent resulting in the nose cone / tip separating in the vessel.The nose cone / tip was successfully retrieved using a snare device.There were no adverse patient sequelae.No additional information was provided.
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