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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC
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COOK IRELAND LTD ZILVER VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description
Zilver vascular final pmcf report (b)(6)((b)(6) organization).Methods: in order to evaluate the cook medical bare metal zilver vascular ses, vqi peripheral vascular intervention (pvi) registry data for procedures performed between january 2017 and april 2023 by physicians participating in the vqi pvi registry were analyzed.All consecutive pvi procedures for treatment of chronic peripheral arterial disease were selected.This file will capture long term outcomes: occlusion of target lesion.Patient outcome: require intervention/additional procedures s=4.Patient/event info: total number of procedures = 1674; total number of patients = 1596 (male = 1032), avg age = 68.2 yrs.
 
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Brand Name
ZILVER VASCULAR SELF-EXPANDING STENT
Type of Device
NIO STENT, ILIAC
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key18373638
MDR Text Key331184617
Report Number3005580113-2023-00130
Device Sequence Number1
Product Code NIO
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 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2023
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 FDA12/21/2023
Distributor Facility Aware Date12/04/2023
Event Location Hospital
Date Report to Manufacturer12/04/2023
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 Age68 YR
Patient SexMale
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