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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; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Catalog Number ZISV6-35-125-6-120-PTX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 11/14/2022
Event Type  Injury  
Event Description
Pt had stents placed in the right sfa via contralateral access from the left.Stents were patent post placement, and case was completed.Access was closed and patient taken off table.Patient became hypotensive and put back on table where it was determined that there was an arterial bleed on the left side.(3005580113-2022-00133) physician accessed the contralateral side to treat the left leg where bleed was.Covered stents placed.Due to this occurrence access was maintained via sheath on the right side.Later on, it was determined that the right leg had thrombosed, (subject of this report) and ekos was placed in the right leg via the contralateral side (left leg).Ekos left in for 48 hours and clot resolved itself.This complaint (subject of this report) will capture the thrombosis that occurred.
 
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Brand Name
ZILVER PTX 35 DRUG-ELUTING STENT
Type of Device
NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key16706624
MDR Text Key312940375
Report Number3005580113-2023-00042
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 Other
Type of Report Initial
Report Date 04/06/2023,04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberZISV6-35-125-6-120-PTX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/16/2023
Event Location Hospital
Date Report to Manufacturer04/06/2023
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;
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