COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 12/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) #: p100022/s027.The zisv6 devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created from the journal article "tsujimura 2020" to investigate stent thrombosis.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.As per the (b)(4) packaging insert which accompanies this device it informs the user about the "potential significant adverse events that may occur in use of this device include, but are not limited to: stent thrombosis." the (b)(4) packaging insert supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.There is no evidence to suggest that the customer did not follow the packaging insert.A definitive root cause could not be determined from the available information.A possible root cause could be attributed the patient¿s pre-existing condition.From the information provided it is known that the patients had symptomatic peripheral arterial disease.It is possible that patient pre-existing conditions caused and/or contributed to thrombus formation.As mentioned above thrombosis is a known inherent risk of endovascular stenting and is listed in the packaging insert as a potential adverse event.However, there is no evidence within the journal article to suggest any device malfunction or deterioration in device characteristics.Therefore, it is more likely that patient pre-existing conditions caused or contributed to thrombus formation.Complaint is confirmed based on customer testimony.According to the initial reporter, intervention/additional procedures were required to prevent permanent impairment/damage.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Tsujimura 2020 ¿clinical outcomes of polymer-free, paclitaxel-coated stents versus 1 stent grafts in 2 peripheral arterial disease patients with femoropopliteal artery lesions.¿ objective: zilver ptx polymer-free, paclitaxel-coated stents and viabahn stent grafts are effective for the treatment of femoropopliteal lesions.The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease (pad) in real-world settings.Procedure: after insertion of a 6- or 7-fr sheath, an intra-arterial bolus of 5000 iu of heparin was injected and supplemented, as required, to maintain an active clotting time of > 200 seconds.A 0.035-, 0.018-, or 0.014-inch guidewire was used to cross the lesion.After the wire was passed, balloon angioplasty was performed at the discretion of each operator.Two types of devices were used: zilver ptx stents and viabahn stent grafts.The device size was chosen to be 1 mm larger than the reference vessel diameter.Post-dilation was performed as necessary at the discretion of each operator.3-year freedom from stent thrombosis was higher in zilver ptx than in viabahn groups (93.6% versus 82.4%, p=0.038) in femoropopliteal lesions.The current study did not collect the detailed data regarding stent thrombosis, such as the cause of stent thrombosis, the frequency of thrombolysis, or the clinical outcome after treatment for stent thrombosis.This file was opened to capture 21 cases of thrombosis in the ptx group.
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