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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT
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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 12/18/2019
Event Type  Injury  
Manufacturer Narrative
Common device name.Niu stent, superficial femoral artery, drug-eluting.
 
Event Description
Phair, 2020, (zilver ptx) ¿ primary patency of long-segment femoropopliteal artery lesions in patients with peripheral arterial occlusive disease treated with paclitaxel-eluting technology.In this retrospective cohort study, a single-center, prospectively maintained database was interrogated to find all consecutive patients undergoing endovascular intervention with paclitaxel-coated balloons and paclitaxel-eluting stents from 2015 to 2018 for long segment (100 mm) femoropopliteal disease.Patients were followed after their index procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography.Target vessel restenosis occurred in 23.7% of patients (n=23).Patient outcome: target vessel restenosis occurred in 23.7% of patients (n=23).
 
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Brand Name
ZILVER PTX 35 DRUG-ELUTING STENT
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key11362113
MDR Text Key241932580
Report Number3005580113-2021-00029
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/19/2021,02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/25/2021
Event Location Hospital
Date Report to Manufacturer02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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