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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT
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COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT Back to Search Results
Model Number G57449
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 01/21/2021
Event Type  Injury  
Manufacturer Narrative
Procode nio stent, iliac.(b)(4).
 
Event Description
Two physicians were deploying two identical stent simultaneously.The delivery system in a pin and pull deployment, however, one physician pushed the hub into the handle.This cause the stent to crimp up on itself and land in the incorrect location.The stent was left in place inside of a cook gianturco-rosch tracheobronchial stent.Another manufacturer's stent was used to stent inside of the zilver vena venous self-expanding stent.After the procedure, the cook representative spoke and confirmed with the physicians, the incorrect deployment of the stent.
 
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Brand Name
ZILVER VENA VENOUS SELF-EXPANDING STENT
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key11313086
MDR Text Key231394382
Report Number3005580113-2021-00018
Device Sequence Number1
Product Code QAN
UDI-Device Identifier10827002574493
UDI-Public(01)10827002574493(17)231020(10)C1769827
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 02/11/2021,02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/20/2023
Device Model NumberG57449
Device Catalogue NumberZVT7-35-80-16-140
Device Lot NumberC1769827
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2021
Distributor Facility Aware Date01/21/2021
Event Location Hospital
Date Report to Manufacturer02/10/2021
Date Device Manufactured10/20/2020
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;
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