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(b)(4).Pma/510(k) #p100022/s001.This investigation deals with the restenosis of ziv6-35-125-7.0-120-ptx stent of lot number c779781 that occurred on the (b)(6) 2017.The ziv6-35-125-7.0-120-ptx stent of lot number c779781 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.Imaging review is currently pending for this complaint.The investigation will be updated following the receipt of the imaging review.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however as no imaging was available at the time of investigation, a definitive root cause of this event cannot be determined at this time.It may be noted that as per the packaging insert, restenosis of the stented artery is a known potential adverse event associated with the placement of this device.It may also be noted that rest pain is outlined as a potential adverse event associated with the placement of this device as per the packaging insert.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has occurred previously with the lot number c779781.However, it was for the same patient restenosis previously occurred on.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c779781.Cutting balloon angioplasty was performed.The patient's condition has been recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.
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Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s001.This investigation deals with the restenosis of ziv6-35-125-7.0-120-ptx stent of lot number c779781 that occurred on the (b)(4) 2017.The ziv6-35-125-7.0-120-ptx stent of lot number c779781 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: findings: implantation angiography, dated 1/22/13 and angiography at secondary interventions (b)(6) 2015, (b)(6) 2016, (b)(6) 2016 and (b)(6) 2017 are provided along with the complaint reports.The imaging demonstrates recanalization of an 11cm long left proximal sfa occlusion followed by stenting of the sfa from its origin through the adductor canal with three zilver ptx stents.The superior and middle stents overlapped 32mm and the middle and distal stents overlapped 11mm for a total stented length of 31.7cm.The initial intervention was performed nearly completely with carbon dioxide.Imaging quality and coverage of the calf runoff was limited.The knee popliteal artery (pa) was narrowed at least 50% and the proximal anterior tibial and posterior tibial arteries were occluded.The only patent proximal calf vessel was a severely, diffusely narrowed peroneal artery.Runoff imaging inferior to the proximal calf was either not performed or not provided.The stents completely expanded the sfa to between 5.2mm and 7mm.Secondary intervention angiography must have followed ultrasound and clinical findings of stenosis based on the reported degree of restenosis a few days prior to each secondary intervention.These ultrasounds were not provided.Because of the long stented length, multiple stents, and multiple secondary interventions, the findings of each provided secondary intervention relative to in-stent stenosis were organized in tabular form.Although use of a cutting balloon was mentioned in each complaint report, cutting balloons are by nature short.The (b)(6) 2015 and (b)(6) 2016 interventions featured relatively short balloons, possibly representing cutting balloons.The (b)(6) 2016 and (b)(6) 2017 interventions only demonstrated very long balloons that could not represent cutting balloons.Runoff imaging was provided in detail on each secondary intervention as a large part of these interventions focused on restoring inline tibial artery blood flow into the foot.The above knee pa was narrowed to 2.9mm on each secondary intervention and was never treated.Recanalization of the posterior tibial artery was performed during each secondary intervention.Each time it was recanalized and even stented, it occluded prior to the next secondary intervention.The occluded anterior tibial artery was also recanalized on the final secondary intervention.Severe atherosclerotic disease was present in the other imaged arteries including the right sfa, the coronary arteries, and the iliac arteries.A left external iliac artery stenosis was eliminated at implantation by stenting.Coronary angiography was included on some of the imaging.Because the secondary interventions were performed with contrast rather than carbon dioxide, the patient had likely progressed from severe chronic kidney disease to dialysis between implantation and the first secondary intervention.Impression: although restenosis from neointimal hyperplasia at each secondary intervention was confirmed, it was only moderate to severe or greater in the proximal and distal stents.The mid stent restenosis was only moderate.Long stented length, poor distal runoff, severe atherosclerotic disease, and hemodialysis increased the risk of significant neointimal hyperplasia.Clinical symptoms, although aggravated by the neointimal hyperplasia, were primarily driven by the calf vessel occlusion rather than in-stent stenosis; otherwise the multiple aggressive attempts at tibial vessel recanalization would not have been performed.Significant findings relative to the patient anatomy were observed.Calf runoff was severely limited by a 50% pa stenosis, anterior and posterior tibial artery occlusion and diffuse severe peroneal artery stenosis.Significant findings relative to the disease state were observed.Overall atherosclerotic disease burden was severe.The patient also was likely on hemodialysis.Significant findings relative to the use of the device were not observed.Significant findings relative to the design or performance of the device were observed.The stents developed recurrent in-stent stenosis from neointimal hyperplasia.Cause of adverse events was not observed.Based on the imaging review, the complaint of restenosis is confirmed, as the stents developed recurrent in-stent stenosis from neointimal hyperplasia.It was noted that possible causes of the in-stent stenosis were as follows: long stented length, poor distal runoff, severe atherosclerotic disease, and hemodialysis increased the risk of significant neointimal hyperplasia.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however a definitive root cause of this event cannot be determined at this time.It may be noted that as per the packaging insert, restenosis of the stented artery is a known potential adverse event associated with the placement of this device.It may also be noted that rest pain is outlined as a potential adverse event associated with the placement of this device as per the packaging insert.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has occurred previously with the lot number c779781.However, it was for the same patient restenosis previously occurred on.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c779781.Balloon angioplasty was performed.The patient's condition has been recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.
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