Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT Back to Search Results
Catalog Number ZVT7-35-80-16-10.0
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 01/30/2021
Event Type  Injury  
Manufacturer Narrative
Procode: nio stent, iliac.(b)(4).
 
Event Description
According to the initial reporter zilver vena broke while being deployed."she was intubated and i ended up bringing her back and putting in an atrium and another zilver vena (this time deployed by me) to traps the fractured portion.I am not sure how stable the system is but i didn't hear anything overnight from them (she's intubated in icu so i can't assess pain reliably)." device was being used for svc syndrome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZILVER VENA VENOUS SELF-EXPANDING STENT
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key11377575
MDR Text Key233592502
Report Number3005580113-2021-00030
Device Sequence Number1
Product Code QAN
UDI-Device Identifier10827002520261
UDI-Public(01)10827002520261(17)220423(10)C1606975
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/24/2021,02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/23/2022
Device Catalogue NumberZVT7-35-80-16-10.0
Device Lot NumberC1606975
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/30/2021
Event Location Hospital
Date Report to Manufacturer02/24/2021
Date Device Manufactured04/23/2019
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;
-
-