Catalog Number ZIV6-35-125-6-100-PTX |
Device Problems
Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/15/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Pma/510(k) #: p100022/s001.(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.
|
|
Event Description
|
(b)(6) pt.Experienced an occlusion/restenosis within the study lesion, probably r/t study product & procedure.One (b)(6) study stent was placed during the index procedure on (b)(6) 2015.On (b)(6) 2015, the patient received one (b)(6) 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?.
|
|
Event Description
|
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?.
|
|
Manufacturer Narrative
|
Pma/510(k) # p100022/s001.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: (b)(4).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: (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.
|
|
Event Description
|
This report is being submitted as a cancellation report based on the receipt of information that the 2nd device this file was opened for was not present.Please refer to 3001845648-2018-00545 for details of the stent which was confirmed to be in place.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?.
|
|
Manufacturer Narrative
|
Pma/510(k) #= p100022/s001.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.This report is being submitted as a cancellation report based on the receipt of information that the 2nd device this file was opened for was not present in the patient.Please refer to 3001845648-2018-00545 for details of the stent which was confirmed to be in place.
|
|
Search Alerts/Recalls
|