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| Catalog Number UNKNOWN |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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| Patient Problem
Inflammation (1932)
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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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As initially reported to customer relations per literature article emailed from cook ireland: introduction: previous studies have reported the clinical outcomes of the zilver ptxtm, a paclitaxel-eluting nitinol stent (cook medical, bloomington, in, usa), in patients with de novo or restenotic lesions of the femoropopliteal artery.Intravascular optical coherence tomography (oct) provides imaging of blood vessels with resolutions at the 10 mm scale.Using this imaging modality, we were able to precisely measure the underlying vascular response at 12-month follow-up after the use of zilver ptx drug-eluting stent in femoropopliteal lesions.Methods: twenty patients with superficial femoral artery (sfa) disease (total occlusions or significant stenosis) were prospectively enrolled in a single-arm study.All patients were treated with balloon angioplasty and implantation of zilver ptxtm des in the sfa followed by imaging with oct.Thirteen patients completed 12- month follow-up to date and reimaging with oct.Variables evaluated included neointimal growth and malposed struts at 1 mm intervals, peri-strut low-intensity area (plia) at 10 mm intervals, and neovessels throughout.The latter two are markers of inflammation.Results: compared to baseline, the mean percentage of malposed struts was significantly less at follow up (11.1% vs.0.3%, p(i/4)0.0001).At follow-up, the mean plia per visible strut was 0.018 mm2 (sd 0.019 mm2), the mean length-normalized neointimal volume was 7.8 mm2 (sd 3.8 mm2), the mean percentage of luminal narrowing was 35% (sd 18%), the mean of the maximum percentage of restenosis was 60% (sd 25%), and the mean number of vessels per mm of stent was 0.125 (sd 0.159).Conclusion: these findings show the current state of disease at 12 months after zilver ptx implantation and suggest persistent inflammation and delayed vascular healing.
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Event Description
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As initially reported to customer relations per literature article emailed from cook ireland: introduction previous studies have reported the clinical outcomes of the zilver ptxtm, a paclitaxel-eluting nitinol stent (cook medical, bloomington, in, usa), in patients with de novo or restenotic lesions of the femoropopliteal artery.Intravascular optical coherence tomography (oct) provides imaging of blood vessels with resolutions at the 10 mm scale.Using this imaging modality, we were able to precisely measure the underlying vascular response at 12-month follow-up after the use of zilver ptx drug-eluting stent in femoropopliteal lesions.Methods twenty patients with superficial femoral artery (sfa) disease (total occlusions or significant stenosis) were prospectively enrolled in a single-arm study.All patients were treated with balloon angioplasty and implantation of zilver ptxtm des in the sfa followed by imaging with oct.Thirteen patients completed 12- month follow-up to date and reimaging with oct.Variables evaluated included neointimal growth and malapposed struts at 1-mm intervals, peri-strut low-intensity area (plia) at 10-mm intervals, and neovessels throughout.The latter two are markers of inflammation.Results compared to baseline, the mean percentage of malapposed struts was significantly less at follow up (11.1% vs.0.3%, p(i/4)0.0001).At follow-up, the mean plia per visible strut was 0.018 mm2 (sd 0.019 mm2), the mean length-normalized neointimal volume was 7.8 mm2 (sd 3.8 mm2), the mean percentage of luminal narrowing was 35% (sd 18%), the mean of the maximum percentage of restenosis was 60% (sd 25%), and the mean number of vessels per mm of stent was 0.125 (sd 0.159).Conclusion these findings show the current state of disease at 12 months after zilver ptx implantation and suggest persistent persistent inflammation and delayed vascular healing.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Reporting based on the cautious approach that intervention/prolonged hospitalization may have been necessary as a result of these events.
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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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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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As initially reported to customer relations per literature article emailed from cook ireland: introduction: previous studies have reported the clinical outcomes of the zilver ptxtm, a paclitaxel-eluting nitinol stent (cook medical, bloomington, in, usa), in patients with de novo or restenotic lesions of the femoropopliteal artery.Intravascular optical coherence tomography (oct) provides imaging of blood vessels with resolutions at the 10 mm scale.Using this imaging modality, we were able to precisely measure the underlying vascular response at 12-month follow-up after the use of zilver ptx drug-eluting stent in femoropopliteal lesions.Methods: twenty patients with superficial femoral artery (sfa) disease (total occlusions or significant stenosis) were prospectively enrolled in a single-arm study.All patients were treated with balloon angioplasty and implantation of zilver ptxtm des in the sfa followed by imaging with oct.Thirteen patients completed 12- month follow-up to date and reimaging with oct.Variables evaluated included neointimal growth and malapposed struts at 1-mm intervals, peri-strut low-intensity area (plia) at 10-mm intervals, and neovessels throughout.The latter two are markers of inflammation.Results: compared to baseline, the mean percentage of malapposed struts was significantly less at follow up (11.1% vs.0.3%, p(i/4)0.0001).At follow-up, the mean plia per visible strut was 0.018 mm2 (sd 0.019 mm2), the mean length-normalized neointimal volume was 7.8 mm2 (sd 3.8 mm2), the mean percentage of luminal narrowing was 35% (sd 18%), the mean of the maximum percentage of restenosis was 60% (sd 25%), and the mean number of vessels per mm of stent was 0.125 (sd 0.159).Conclusion: these findings show the current state of disease at 12 months after zilver ptx implantation and suggest persistent persistent inflammation and delayed vascular healing.
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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.- attachment: [shaar literature article.Pdf].
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Event Description
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As initially reported to customer relations per literature article emailed from cook ireland: introduction previous studies have reported the clinical outcomes of the zilver ptxtm, a paclitaxel-eluting nitinol stent (cook medical, bloomington, in, usa), in patients with de novo or restenotic lesions of the femoropopliteal artery.Intravascular optical coherence tomography (oct) provides imaging of blood vessels with resolutions at the 10 mm scale.Using this imaging modality, we were able to precisely measure the underlying vascular response at 12-month follow-up after the use of zilver ptx drug-eluting stent in femoropopliteal lesions.Methods twenty patients with superficial femoral artery (sfa) disease (total occlusions or significant stenosis) were prospectively enrolled in a single-arm study.All patients were treated with balloon angioplasty and implantation of zilver ptxtm des in the sfa followed by imaging with oct.Thirteen patients completed 12- month follow-up to date and reimaging with oct.Variables evaluated included neointimal growth and malapposed struts at 1-mm intervals, peri-strut low-intensity area (plia) at 10-mm intervals, and neovessels throughout.The latter two are markers of inflammation.Results compared to baseline, the mean percentage of malapposed struts was significantly less at follow up (11.1% vs.0.3%, p(i/4)0.0001).At follow-up, the mean plia per visible strut was 0.018 mm2 (sd 0.019 mm2), the mean length-normalized neointimal volume was 7.8 mm2 (sd 3.8 mm2), the mean percentage of luminal narrowing was 35% (sd 18%), the mean of the maximum percentage of restenosis was 60% (sd 25%), and the mean number of vessels per mm of stent was 0.125 (sd 0.159).Conclusion these findings show the current state of disease at 12 months after zilver ptx implantation and suggest persistent persistent inflammation and delayed vascular healing.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Reporting based on the cautious approach that intervention/prolonged hospitalization may have been necessary as a result of these events.
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Manufacturer Narrative
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Event is no longer meets the requirements of a serious injury report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13.Clinical input confirms prolonged hospitalisation or treatment was not required as a result of inflammation.This report is being submitted as a cancellation report.Device evaluation: this file is related to (b)(4) and (b)(4).Each file investigates persistent inflammation.The zilver ptx 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 zilver ptx 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 the instructions for use (ifu0118-5) states the following: ¿histologic changes in vessel wall, including inflammation, cellular damage or necrosis.¿ there is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to implantation of the stent and/or the drug coating on the stent.Implantation of any foreign matter object or device into the body can result in inflammation.It is also possible that the paclitaxel drug coating on the stent contributed to the inflammation.However, as more information is not available within the article, a definitive root cause could not be determined.Summary: the complaint is confirmed based on customer testimony.It is unknown as to whether or not the patients required any intervention as a result of this event.It is known that the study concluded that vascular healing was delayed as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.- attachment: [shaar literature article.Pdf].
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Event Description
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As initially reported to customer relations per literature article emailed from cook ireland: introduction: previous studies have reported the clinical outcomes of the zilver ptxtm, a paclitaxel-eluting nitinol stent (cook medical, bloomington, in, usa), in patients with de novo or restenotic lesions of the femoropopliteal artery.Intravascular optical coherence tomography (oct) provides imaging of blood vessels with resolutions at the 10 mm scale.Using this imaging modality, we were able to precisely measure the underlying vascular response at 12-month follow-up after the use of zilver ptx drug-eluting stent in femoropopliteal lesions.Methods: twenty patients with superficial femoral artery (sfa) disease (total occlusions or significant stenosis) were prospectively enrolled in a single-arm study.All patients were treated with balloon angioplasty and implantation of zilver ptxtm des in the sfa followed by imaging with oct.Thirteen patients completed 12- month follow-up to date and reimaging with oct.Variables evaluated included neointimal growth and malapposed struts at 1-mm intervals, peri-strut low-intensity area (plia) at 10-mm intervals, and neovessels throughout.The latter two are markers of inflammation.Results: compared to baseline, the mean percentage of malapposed struts was significantly less at follow up (11.1% vs.0.3%, p(i/4)0.0001).At follow-up, the mean plia per visible strut was 0.018 mm2 (sd 0.019 mm2), the mean length-normalized neointimal volume was 7.8 mm2 (sd 3.8 mm2), the mean percentage of luminal narrowing was 35% (sd 18%), the mean of the maximum percentage of restenosis was 60% (sd 25%), and the mean number of vessels per mm of stent was 0.125 (sd 0.159).Conclusion: these findings show the current state of disease at 12 months after zilver ptx implantation and suggest persistent persistent inflammation and delayed vascular healing.
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Search Alerts/Recalls
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