COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Catalog Number UNKNOWN |
Device Problems
Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stenosis (2263); Restenosis (4576)
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Event Date 05/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Soga et al 2019 (zilver ptx) ¿ ¿one-year late lumen loss between a polymer-coated paclitaxel-eluting stent (eluvia) and a polymer-free paclitaxel-coated stent (zilver ptx) for femoropopliteal disease¿.A 0.035, 0.018 or 0.014 inch wireguide was used to cross the lesion.After passing the wire, balloon angioplasty was performed.All lesions were dilated with an optimally sized balloon.Two types of drug-eluting stents were used: eluvia (boston scientific) n=49 and zilver ptx (cook medical) n=17.The stent size was chosen to be 1mm larger than the reference vessel diameter.The lesion has to be fully covered with eluvia or zilver ptx.The binary restenosis rate at one year was significantly lower in the eluvia group, at 0% (0/36), than it was in the zilver ptx group, at 16.7% (2/12).
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Manufacturer Narrative
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Device evaluation: the unknown device of unknown lot number 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.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 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 it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0122-3).There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing conditions included hypertension, dyslipidaemia , diabetes, smoking, coronary artery disease (cad), history of ischemic stroke or transient ischemic attack, obesity and rutherford classifications between 2 and 4.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.Summary: complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Supplemental report is being submitted due to the completion of the investigation.
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Search Alerts/Recalls
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