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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 12/22/2015
Event Type  Injury  
Manufacturer Narrative
Common device name: niu stent, superficial femoral artery, drug-eluting.
 
Event Description
Banerjee et al 2015 (zilver ptx) ¿ ¿femoropopliteal artery stent thrombosis report from the (b)(6) registry¿.Index procedures resulting in femoropopliteal st were compared with stent procedures without subsequent st in the excellence in peripheral artery disease registry.The study data had a total of 724 cases of stent procedures and 604 unique patients.Stent thrombosis: st occurred in 3 of 68 zilver ptx drug-coated stent cases (4.4%).Patient 1 required balloon angioplasty and dcs, patient 2 required surgical intervention and patient 3 required thrombectomy, balloon angioplasty.
 
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Brand Name
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key13577248
MDR Text Key290545419
Report Number3005580113-2022-00025
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 02/18/2022,02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Date01/24/2022
Event Location Hospital
Date Report to Manufacturer02/18/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/22/2022
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 Age63 YR
Patient SexMale
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