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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Catalog Number ZISV6-35-125-5.0-120-PTX
Device Problem Obstruction of Flow (2423)
Patient Problem Occlusion (1984)
Event Date 01/22/2018
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) #: p100022/s014.
 
Event Description
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522 = zisv6-35-125-5.0-80-ptx; zisv6-35-125-5.0-120-ptx; 3001845648-2018-00521 = unknown stent (assumed zisv6-ptx); 3001845648-2018-00522 = unknown stent (assumed zisv6-ptx).On (b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) feb-2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
 
Event Description
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522 = zisv6-35-125-5.0-80-ptx.3001845648-2018-00520 = zisv6-35-125-5.0-120-ptx.3001845648-2018-00521 = unknown stent (assumed zisv6-ptx).3001845648-2018-00522 = unknown stent (assumed zisv6-ptx).On (b)(6) 2018 - (b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) 2018 - (b)(6) 2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
 
Manufacturer Narrative
Pma/510(k) # = p100022/s014.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.Device evaluation: the zisv6-35-125-5.0-120-ptx device of lot number c1287834 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 : prior to distribution zisv6-35-125-5.0-120-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.A review of the manufacturing records for zisv6-35-125-5.0-120-ptx of lot number c1287834 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has previously occurred with the current lot number.There is no requirement to take action as the stent of lot number c1287834 had been implanted in the patient prior to this event.This was a new event within the same patient and as a result of a number of stents being previously implanted in the patient; it could not be confirmed as to which stent the occlusion occurred within and so each stent implanted in the patient at the time could have been the occluded stent.Each stent will be investigated individually.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1287834.There is no evidence to suggest that the customer did not follow the instructions for use.However, it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the ifu.Image review: a number of attempts have been made to obtain imaging for review.However, at the time of the investigation, this was not available.The investigation will be updated when the images are received by cook ireland.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause for restenosis could be attributed to the patient¿s pre-existing conditions.From the information provided, it is known that the patient has a history of hypertension, hypercholesterolemia and is a current smoker.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.According to the initial reporter, an additional stent was placed as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Manufacturer Narrative
Pma/510(k) # = p100022/s014.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).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522 = zisv6-35-125-5.0-80-ptx.3001845648-2018-00520 = zisv6-35-125-5.0-120-ptx.3001845648-2018-00521 = unknown stent (assumed zisv6-ptx).3001845648-2018-00522 = unknown stent (assumed zisv6-ptx).On (b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) 2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
 
Manufacturer Narrative
Pma/510(k) # = p100022/s014.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.
 
Event Description
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522 = zisv6-35-125-5.0-80-ptx.3001845648-2018-00520 = zisv6-35-125-5.0-120-ptx.3001845648-2018-00521 = unknown stent (assumed zisv6-ptx).3001845648-2018-00522 = unknown stent (assumed zisv6-ptx).On (b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) 2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
 
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Brand Name
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Type of Device
NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8045423
MDR Text Key126351530
Report Number3001845648-2018-00520
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup,Followup,Followup
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/17/2018
Device Catalogue NumberZISV6-35-125-5.0-120-PTX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/07/2018
Event Location Hospital
Date Manufacturer Received10/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight66
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