Model Number G24888 |
Device Problems
Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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(b)(6), pt.Experienced an occlusion/restenosis within the study lesion, probably r/t study product & procedure.One zilver® ptx® v study stent was placed during the index procedure on (b)(6) 2015 on (b)(6) 2015, the patient received one zilver ptx study stent in the right proximal sfa via a contralateral access site.The study lesion was 20.0 mm in length with 70% diameter stenosis in study lesion.Pre-stent dilatation was not performed.Post-stent dilatation was performed.There was no thrombus or dissection post stenting, with no residual stenosis remaining.On (b)(6) 2018 (980 days post-procedure), the patient experienced worsened an occlusion/restenosis within the study lesion.Treatment included atherectomy and drug coated balloon angioplasty on (b)(6) 2018 (994 days post-procedure).[note, the site has not submitted the secondary intervention form yet, no further information is available.The event was considered probably related to the study product and the study procedure.[the site has been queried regarding rationale for probably related to study procedure.] pre-existing peripheral arterial disease was also noted to have caused or contributed to the event.The site marked no to the question: did the device malfunction or deteriorate in characteristics or performance?.
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Event Description
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This report is being submitted as a cancellation report.The complaint is not confirmed as the defect could not be verified in the image(s).In stent restenosis could not be verified in the imaging review.12-004, pt.Experienced an occlusion/restenosis within the study lesion, probably r/t study product & procedure.One zilver® ptx® v study stent was placed during the index procedure on (b)(6) 2015.On(b)(6) 2015, the patient received one zilver ptx study stent in the right proximal sfa via a contralateral access site.The study lesion was 20.0 mm in length with 70% diameter stenosis in study lesion.Pre-stent dilatation was not performed.Post-stent dilatation was performed.There was no thrombus or dissection post stenting, with no residual stenosis remaining.On (b)(6) 2018 (980 days post-procedure), the patient experienced worsened an occlusion/restenosis within the study lesion.Treatment included atherectomy and drug coated balloon angioplasty on(b)(6) 2018 (994 days post-procedure).[note, the site has not submitted the secondary intervention form yet, no further information is available.The event was considered probably related to the study product and the study procedure.[the site has been queried regarding rationale for probably related to study procedure.] pre-existing peripheral arterial disease was also noted to have caused or contributed to the event.The site marked no to the question: did the device malfunction or deteriorate in characteristics or performance?.
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Manufacturer Narrative
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Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This report is being submitted as a cancellation report.Images were provided to support the complaint investigation.As per image review there is no evidence of in-stent restenosis from the image(s) provided for this complaint.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: 1.The complaint of ziv6-35-125-6-40-ptx stenosis cannot be confirmed as imaging of event was not provided.The provided image before and after the reported secondary intervention did not demonstrate a stenosis.2.The one-year ultrasound (b)(6) 2016 maybe from a different patient.Complaint is not confirmed as the defect could not be verified in the image(s).In stent restenosis could not be verified in the imaging review.
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Manufacturer Narrative
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Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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12-004, pt.Experienced an occlusion/restenosis within the study lesion, probably r/t study product & procedure.One zilver® ptx® v study stent was placed during the index procedure on 09-oct-2015 on (b)(6) 2015, the patient received one zilver ptx study stent in the right proximal sfa via a contralateral access site.The study lesion was 20.0 mm in length with 70% diameter stenosis in study lesion.Pre-stent dilatation was not performed.Post-stent dilatation was performed.There was no thrombus or dissection post stenting, with no residual stenosis remaining.On (b)(6) 2018 (980 days post-procedure), the patient experienced worsened an occlusion/restenosis within the study lesion.Treatment included atherectomy and drug coated balloon angioplasty on (b)(6) 2018 (994 days post-procedure).[note, the site has not submitted the secondary intervention form yet, no further information is available.The event was considered probably related to the study product and the study procedure.[the site has been queried regarding rationale for probably related to study procedure.] pre-existing peripheral arterial disease was also noted to have caused or contributed to the event.The site marked no to the question: did the device malfunction or deteriorate in characteristics or performance?.
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Search Alerts/Recalls
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