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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
The patient presented at medical center for an unknown reason and was sent to another medical center to have the filter removed.The patient contacted the implanting physician, to report that the filter had migrated down slightly, and one foot had flipped upward.Upon removal of the filter, there was bleeding and a covered endograft was placed to control bleeding in the ivc.Patient was overall good.
 
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Brand Name
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key15734954
MDR Text Key303075481
Report Number3005580113-2022-00115
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/04/2022
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? Yes
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2022
Distributor Facility Aware Date10/14/2022
Event Location Hospital
Date Report to Manufacturer11/03/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/04/2022
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 SexMale
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