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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
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COOK IRELAND LTD ZILVER PTX DRUG ELUTING PERIPHERAL STENT Back to Search Results
Catalog Number UNKNOWN
Device Problem Fracture (1260)
Patient Problem Embolus (1830)
Event Type  Injury  
Manufacturer Narrative
Procode: niu stent, superficial femoral artery, drug-eluting.
 
Event Description
Two 7mm zilver ptx stents were placed in the patient in 2015.During a post thrombolysis, it was noted that there was flow behind the stent struts (3005580113-2019-00642) and also stent fractures (subject of this report).Drip tpa was administered to dissolve the clot, and a and a 7 x 250 gore viabahn covered stent was placed.The patient outcome was noted to be stable/good.Imaging review determined a type 1 stent fracture unrelated to blood flow behind stents.Imaging review confirmed restenosis.
 
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Brand Name
ZILVER PTX DRUG ELUTING PERIPHERAL STENT
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key9588507
MDR Text Key188815758
Report Number3005580113-2020-00059
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
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? Yes
Date Report Sent to FDA01/14/2020
Distributor Facility Aware Date01/03/2020
Event Location Hospital
Date Report to Manufacturer01/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight78
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