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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 Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
The doctor mentioned to the wca rep during a conversation that he had two ptx stent fractures.No specific details were available at the time however he advised he would look up the patients and possibly images.(b)(4) are related (two stent fracture events).
 
Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).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
The doctor mentioned to the wca rep during a conversation that he had two ptx stent fractures.No specific details were available at the time however he advised he would look up the patients and possibly images.(b)(4) are related (two stent fracture events).
 
Event Description
The doctor mentioned to the wca rep during a conversation that he had two ptx stent fractures.No specific details were available at the time however he advised he would look up the patients and possibly images.(b)(4) are related (two stent fracture events).
 
Manufacturer Narrative
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).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Device evaluation: the unknown 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.Three attempts have been made to obtain additional information regarding this case.However, no information has been received at this time.The investigation will be updated should any information be made available to cirl in the future.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 all zisv6-ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.There is no evidence to suggest that the customer did not follow the instructions for use.However, it may be noted that the instructions for use lists stent strut fracture as a known potential adverse event.Root cause review: as there was limited information provided for this investigation and as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.However, a possible root cause could be attributed to interaction with an overlapped stent and /or stent location.If the stent was overlapped with another stent and the overlapped section was not sufficient, additional stress may have been placed on both stents possibly causing and/or contributing to stent fracture.If the stent was placed around the knee or crossed beneath the inguinal ligament, additional stress could have been placed on the stent during hip and/or knee flexion.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, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
 
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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 Key7969292
MDR Text Key126095097
Report Number3001845648-2018-00490
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
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/16/2018
Event Location Hospital
Date Manufacturer Received09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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