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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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| Catalog Number ZIV6-35-125-6-100-PTX |
| Device Problem
Occlusion Within Device (1423)
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| Patient Problems
Pain (1994); Claudication (2550)
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| Event Date 08/25/2015 |
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) # p100022/s100.This incident has been deemed mdr reportable based on the intervention carried out (preoperative heparin infusion, atherectomy, balloon angioplasty, and stent placement) as a result of worsening claudication/rest pain at the site where a zilver ptx stent was indwelling.The information received relating to this event is currently being investigated.A follow up mdr will be submitted with the investigation conclusions.
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Event Description
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Protocol 12-004, patient (b)(6): on (b)(6) 2015, the patient underwent pre-dilatation of the study lesion before one 6 mm x 100 mm zilver ptx v study stent (lot # c1096737) was placed via contralateral access.The implanting physician noted that ease of device deployment was easy.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was opposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.On (b)(6) 2015 (126 days post procedure), the patient underwent a secondary intervention in the study lesion due to worsening claudication/rest pain.Treatment included a preoperative heparin infusion, atherectomy, balloon angioplasty, and stent placement.The treating physician stated that this event was probably related to the study product, not related to the study procedure, and cited peripheral vascular disease as a pre-existing condition that caused or contributed to the event.
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Manufacturer Narrative
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Pma/510(k) # p100022/s100.The ziv6-35-125-6-100-ptx stent of lot number c1096737 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Available information stated that the patient had pre-existing conditions including: coronary artery disease, hypertension, and hypercholesterolemia.From the patient¿s pre-existing conditions provided with this complaint, it is known that the patient had potential risk factors for thrombosis such as hypertension and hypercholesterolemia images were provided to support the complaint investigation.These were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: ¿findings: ¿¿.6.The secondary intervention was performed 4 months later.7.The intervention was performed from the right common femoral artery (cfa).A right leg runoff was performed initially and demonstrated complete mid and distal right sfa occlusion.8.Abdominal and pelvic angiography that followed demonstrated no inflow stenosis to either leg with the caveat that each cfa was obscured by hip prostheses.9.The left sfa stents were occluded from 20mm inferior the proximal stent (complaint stent) superior margin through the pre-existing stent and 20mm beyond into the sfa.10.Over the next 17 minutes, the short right cfa sheath was exchanged for a long sheath, at least 45cm, the occlusion crossed, and the distal runoff imaged.The left pta and peroneal artery were still patent into the foot and distal calf respectively while the anterior tibial artery was demonstrated patent to the mid-calf.11.After placing a filter wire in the left popliteal artery, orbital atherectomy was then performed with a csi catheter.Because only imaging of atherectomy in the mid pre-existing zilver stent was provided, it is unclear how much, if any, of the complaint stent was treated with atherectomy.12.Post atherectomy angiography demonstrated no stenosis in the complaint stent, 30% residual stenosis in the pre-existing stent and a 30mm long 50% sfa stenosis distal the pre-existing stent.Emboli were imaged in the filter (spider fx).13.After filter removal, the best calf imaging yet provided demonstrated small partially occlusive peroneal artery emboli and a normal left anterior tibial artery to the ankle.14.Additional angioplasty through the stents and the distal sfa stenosis improved the per-existing stent stenosis and the distal sfa stenosis however the distal sfa stenosis was still 30% and newly dissected.15.This was then stented with a supera stent from the pre-existing stent through the adductor canal to the popliteal artery.Final angiography demonstrated no residual stenosis.Impression: 1.The complaint stent¿s complete rapid and clearance, possible with orbital atherectomy, combined with the pre-existing stent neointimal hyperplasia and the distal sfa progressive stenosis support complaint stent thrombosis due to a downstream occlusion.This occlusion occurred likely in the distal sfa from atherosclerotic plaque and likely thrombus.It was this lesion that was aggressively eliminated with atherectomy and stenting.2.The complaint stent was completely free of neointimal hyperplasia." based on the imaging review, occlusion occurred likely in the distal sfa from atherosclerotic plaque and likely thrombus.The occlusion was treated with atherectomy and additional stenting.The customer complaint can be confirmed as imaging revealed occlusion.According to the complaint information, the physician stated peripheral vascular disease as a pre-existing condition caused or contributed to this event.However, a definitive root cause cannot be determined.As per the instructions for use, arterial thrombosis is a known potential adverse event associated with placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.According to information provided, treatment included a preoperative heparin infusion, atherectomy, balloon angioplasty, and stent placement.No other adverse events have been reported for this patient and he remains in the study.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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Event Description
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This follow up report is being submitted due to the receipt and review of images relating to this event.This follow up report is being submitted due to the receipt and review of images relating to this event.Initial event description as follows: protocol 12-004, patient (b)(6): on (b)(6) 2015, the patient underwent pre-dilatation of the study lesion before one 6 mm x 100 mm zilver® ptx® v study stent (lot # c1096737) was placed via contralateral access.The implanting physician noted that ease of device deployment was easy.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was opposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.On (b)(6) 2015 (126 days post procedure), the patient underwent a secondary intervention in the study lesion due to worsening claudication/rest pain.Treatment included a preoperative heparin infusion, atherectomy, balloon angioplasty, and stent placement.The treating physician stated that this event was probably related to the study product, not related to the study procedure, and cited peripheral vascular disease as a pre-existing condition that caused or contributed to the event.
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Manufacturer Narrative
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Pma/510(k) # p100022/s100.This incident has been deemed mdr reportable based on the intervention carried out (preoperative heparin infusion, atherectomy, balloon angioplasty, and stent placement) as a result of worsening claudication/rest pain at the site where a zilver ptx stent was indwelling.The ziv6-35-125-6-100-ptx stent was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images are available to support the complaint investigation.The investigation will be updated upon receipt of imaging review and a follow-up mdr will be submitted.Available information stated that the patient had pre-existing conditions including: coronary artery disease, hypertension, and hypercholesterolemia.According to complaint information provided, worsened claudication and rest pain was observed on the patient.It can be noted that this symptom indicates progression of peripheral artery disease and can also be associated with the restenosis process.According to the complaint information, the physician stated peripheral vascular disease as a pre-existing condition caused or contributed to this event.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 cause of this event cannot be determined.As imaging review has not yet been received the complaint is confirmed based on customer testimony.As per the instructions for use, worsened claudication/rest pain and restenosis of the stented artery are known potential adverse events associated with placement of this device.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.According to information provided, treatment included a preoperative heparin infusion, atherectomy, balloon angioplasty, and stent placement.No other adverse events have been reported for this patient and he remains in the study.The physician stated peripheral vascular disease as a pre-existing condition caused or contributed to this event.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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Event Description
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This follow up mdr is being submitted to provide details of the investigation conclusion.Initial event description as follows: protocol (b)(6), patient (b)(6): on (b)(6) 2015, the patient underwent pre-dilatation of the study lesion before one 6 mm x 100 mm zilver® ptx® v study stent (lot # c1096737) was placed via contralateral access.The implanting physician noted that ease of device deployment was easy.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was opposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.On (b)(6) 2015 (126 days post procedure), the patient underwent a secondary intervention in the study lesion due to worsening claudication/rest pain.Treatment included a preoperative heparin infusion, atherectomy, balloon angioplasty, and stent placement.The treating physician stated that this event was probably related to the study product, not related to the study procedure, and cited peripheral vascular disease as a pre-existing condition that caused or contributed to the event.
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