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 Problems
Restenosis (4576); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k)#: p100022/s027.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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The long-term clinical performance of the zilver ptx stent for femoropopliteal lesions is unclear.A single-center retrospective study was conducted on 101 limbs of 83 patients with zilver ptx stents placed between july 2012 and april 2013.Target lesion revascularization avoidance rate (ff-tlr) 10 years after treatment, major adverse limb event avoidance rate (ff-male), and major amputation-free survival rate (afs) were the endpoints.Ff-tlr, ff-male, and afs were 60%, 54%, and 57%.Long-term clinical results were reasonable.This file will capture 40% of 83 patients were affected by tlr; 33 patients / devices.
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Event Description
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Supplemental report is being submitted due to the completion of the investigation on 11-dec-2023.
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Manufacturer Narrative
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Pma/510(k) # p100022/s027.Device evaluation: the zilver ptx drug-eluting peripheral stent devices of rpn and lot numbers unknown 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 complaint is related to (b)(4) and was raised from a single-center retrospective study that was conducted on 101 limbs of 83 patients with zilver ptx stents placed between july 2012 and april 2013.This complaint captures 40% of 83 patients were affected by tlr = 33 patients/devices.The device evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution all zilver ptx drug-eluting peripheral stent devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data review: historical data was not reviewed as the lot number is unknown.Ifu/label review: the japanese packaging insert c-ci1502m06 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.This lists restenosis or occlusion of the stented artery as a potential adverse event.There is no evidence to suggest the user did not follow the japanese packaging insert.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined.A possible root cause could have likely been attributed to patients¿ anatomy/pre existing conditions.From the information available, it is known that the study was to determine the clinical performance of the zilver ptx device on patients with femoropopliteal lesions.Restenosis of the stented artery is also listed as a known potential adverse event within the japanese packaging insert 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.Tlr is an intervention used to treat restenosis confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Summary: according to the initial reporter, the long-term clinical performance of the zilver ptx stent for femoropopliteal lesions is unclear.A single-center retrospective study was conducted on 101 limbs of 83 patients with zilver ptx stents placed between july 2012 and april 2013.Confirmed quantity of 33 devices, confirmed used.According to the initial reporter, revascularization of the target lesion (tlr) was needed in 33 patients over the 10 year period of the study.Long-term clinical results were reasonable.Investigation findings conclude a possible root cause could have likely been attributed to patients¿ anatomy/pre existing conditions.Complaints of this nature will continue to be monitored for potential emerging trends.
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