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Model Number FREDJR2513 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for analysis.The investigation is underway.Images supplied by the distributor were reviewed by microvention's product safety physician: one radiographic image shows what appears to be a broken fred jr.Delivery wire, but it does not appear to be in the patient's anatomy.This image is consistent with the complaint of a broken pusher wire.The broken wire was reported to have occurred upon removal of the wire from the patient.Two cta images were provided that demonstrate two implanted stents in the cerebral vasculature, one distal to the other in the same vessel.The delivery wire is not visible.Images of the actual fred deployment were not provided; therefore, the alleged resheathing difficulty cannot be confirmed.The instructions for use (ifu) identifies thrombosis as a potential complication associated with use of the device.
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Event Description
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It was reported that while repositioning a fred device at the treatment site, resistance was encountered and the fred could be advanced, but not recaptured into the microcatheter; therefore, the fred was completely advanced out of the microcatheter and implanted approximately 7mm above the intended treatment site.Another stent was deployed to fully cover the intended treatment site.The delivery sire detached upon removal from the patient.There was no reported patient injury.The patient has been discharged from the hospital and is currently doing "good.".
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Manufacturer Narrative
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The pusher was returned for evaluation.The stent was not returned.Upon initial inspection, the pusher was found broken proximal to the stainless steel coil.The pusher was sent out for further sem analysis, which identified the mode of the pusher break to be tensile overload.The reported complaint pusher break is confirmed, as the returned pusher was found to be broken, as reported.The pusher displayed a "cup cone" fracture with ductile dimples.This is a result of microvoid coalescence that occurs during tensile overload of ductile material.The small size of the dimples is consistent with a very high tensile strength material, the complex mixture of shear dimples and equiaxed dimples identified the point of final break, with some twisting contributing to the direction of the ductile dimples.While it is possible that the tensile overload of the pusher and eventual breaking of the wire occurred as a result of manipulating the device during attempts to re-sheath the device, the exact circumstances leading up to the break are not known.Since the fred jr.Was implanted in the patient and the microcatheter used was also not returned for evaluation, further investigation into probable causes that contributed to the reported difficulty re-sheathing the device was not possible.
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Search Alerts/Recalls
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