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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34505
Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Thrombosis (2100); Perforation of Vessels (2135); Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: non-healthcare professional. Name and address for importer site: (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] received a celect filter on (b)(6) 2015". Patient allegedly received an implant on (b)(6) 2011 via the right femoral vein due to "deep vein thrombosis, pulmonary embolism and preoperatively for spinal surgery. " patient is alleging "tilt, vena cava perforation, organ perforation, caval thrombosis, thrombosis in ivc". The first filter had prongs protruding outside wall of the ivc; suffered a caval thrombosis, and thrombosis in the ivcf((b)(4)); the current filter has moved backwards and is poking into my intestines ((b)(4)); and i experience chest cramping, and heaviness in chest area. I also experience anxiety, mental anguish and stress about the status of my filter and any related injuries. " patient outcome: patient alleges "i am not certain which specific symptoms or bodily injuries i may have suffered as a result of the cook inferior vena cava filters. I am relying on the experts that will be retained by my lawyer to determine this information.
 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key8159084
MDR Text Key130168863
Report Number3002808486-2018-01473
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/20/2018
Device Model NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device Lot NumberE3295578
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/12/2018
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
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