Pma/510(k) # = p100022/s026.(b)(4).Device evaluation: the zisv6-35-125-6-140-ptx device of lot number c1525770 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.There was 5 cook stents involved in this event.Reference pr252461 (2 stents), pr253168 (1 stent), pr253170 (1 stent), pr253171 (1 stent).Document review: prior to distribution all zilver zisv6 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records (c1525770) revealed no discrepancies that could have contributed to this complaint.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1525770 there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: this event of the patient undergoing amputation post stent placement was likely not stent related.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The patient did undergo amputation which was likely not stent related.Complaints of this nature will continue to be monitored for potential emerging trends.
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On (b)(6) 2018 an arteriogram of the lower leg with balloon angioplasty and stent placement was performed and 5 cook stents were placed.No flow was noted, and the physician indicated they did not believe it was due to the devices.On (b)(6) 2019 the dm followed up to check on the patient, and the physician informed the dm that the patient had to have amputation (unknown location).Patient is stable and healing well.Update per dm on (b)(6) 2019: "the wire used in the case was a terumo stiff straight glide wire.I have not been able to get imaging of the stents.After stent deployment there was no flow, i asked the physician if they thought it was related to the stents and they said no.".
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