(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Movement was restored to left lower extremity, significant motor impairment of the left upper extremity was still present, patient was able to somewhat adjust posture, patient had no right side symptoms, and patient was responsive to commands.Patient speech status remains unknown due to recent extubation.Physician remains hopeful of continued patient recovery.No additional information was provided.Concomitant medical products: dilatation catheter: viatrac 14 (x2), guide catheter: 6fr shuttle guiding sheath, embolic protection: emboshield nav6.The device was not returned for evaluation.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 identified no other similar incidents reported from this lot.The reported patient effect of intimal dissection is listed in the instructions for use as a known patient effect that may be associated with use of a peripheral stent in native peripheral arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The emboshield nav6 device referenced in describe event or problem and concomitant medical products is being filed under a separate manufacturing report number.
|
It was reported that the procedure performed on (b)(6) 2017 was to treat a non-calcified lesion in the very tortuous right internal carotid artery (rica) (2 cm distal to a bifurcation).After positioning a 6fr non-abbott guiding sheath, an emboshield nav6 embolic protection system (eps) delivery catheter with filter was prepped without issue and the filter was deployed distal to the lesion.An rx.014 acculink ii 6-8/40 stent was deployed without difficulty.The emboshield nav6 retrieval catheter (rc) was advanced; the rc was unable to completely cross through the acculink stent due to vessel tortuosity.During the attempt to cross, the non-abbott guiding sheath consequently became unseated / prolapsed due to vessel tortuosity, pulling the wire and filter proximally, resulting in the filter being snagged by the implanted stent.No damage was caused to the stent.The non-abbott sheath could not be re-seated due to the tortuosity.Two viatrac 14 balloons were used for attempts to retrieve the filter.After approximately 7 hours of attempting to retrieve the filter, a dissection was noted at the stent (with the dissection cause unknown); the dissection was successfully treated via placement of two unspecified stents.The patient was then transferred to surgery and the filter was successfully retrieved.A computerized tomography (ct) scan showed a watershed stroke with perfusion, reportedly likely caused by the filter removal surgery, as the rica was clamped distal to the device.The patient was intubated.On (b)(6) 2017, the patient was extubated with the following status:.
|