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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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COOK IRELAND LTD; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Type  Injury  
Manufacturer Narrative
510(k) number: p100022/s014.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Implant of the device happened 6 years ago with no adverse event during the procedure.However, the physician has communicated to the sbu rep that during a recent follow up of this patient he noticed the formation of aneurysmal segments located where a zilver ptx stent was implanted.
 
Event Description
Implant of the device happened 6 years ago with no adverse event during the procedure.However, the physician has communicated to the sbu rep that during a recent follow up of this patient he noticed the formation of aneurysmal segments located where a zilver ptx stent was implanted.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.Aneurysms meet the criteria of a life threatening injury.
 
Manufacturer Narrative
510(k) number: 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: (b)(4).Device evaluation: the ziv6-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.Lab evaluation ¿ n/a.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 ziv6-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.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0117-3).However, it should be noted that arterial aneurysm is listed as a known potential adverse event within the ifu.Image review ¿ n/a.Root cause review a definitive root cause could not be determined from the available information and as images were not available for review.As the condition of the stent and the size and location of the aneurysm are not known, it is not possible to conclude a root cause for this complaint.However, it is known that vessel damage or stent fracture, malapposition or migration resulting in trauma to the vessel can lead to aneurysm formation.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did receive some medical intervention as a result of this occurrence.However, it is unknown at this time what exact intervention was performed.The investigation will be updated to include this information if and when it is received by cirl.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Implant of the device happened 6 years ago with no adverse event during the procedure.However, the physician has communicated to the sbu rep that during a recent follow up of this patient he noticed the formation of aneurysmal segments located where a zilver ptx stent was implanted.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.Aneurysms meet the criteria of a life threatening injury.
 
Manufacturer Narrative
(b)(4).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.
 
Manufacturer Narrative
510(k) number: 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: ed sutkowski 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.
 
Event Description
Implant of the device happened 6 years ago with no adverse event during the procedure.However, the physician has communicated to the sbu rep that during a recent follow up of this patient he noticed the formation of aneurysmal segments located where a zilver ptx stent was implanted.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.Aneurysms meet the criteria of a life threatening injury.
 
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Type of Device
NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8385788
MDR Text Key137672040
Report Number3001845648-2019-00082
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 company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/04/2019
Event Location Hospital
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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