510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4), cook medical incorporated (cmi) 1025 acuff road, p.O box 4195, bloomington, indiana, 47402-4195.Importer site establishment registration number:(b)(4).Device evaluation: the zisv6-35-125-7-40-ptx device of lot number c1515539 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 28th march 2019.The device flushed as expected, a 0.035¿ wire guide was passed through the device with no issues and the device deployed with no issues.Document review: prior to distribution zisv6-35-125-7-40-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zisv6-35-125-7-40-ptx of lot number c1515539 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1515539.It should be noted that the instructions for use states the following: ¿the zilver ptx drug-eluting peripheral stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths of up to 300 mm per patient.¿ root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the device being used in a location that is not indicated within the ifu.It is possible that use of the device in the celiac artery caused and/or contributed to resistance during advancement.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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