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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

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CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO) Back to Search Results
Catalog Number 466P306X
Device Problem Occlusion Within Device (1423)
Patient Problem Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
Please note that device reported is an trapease vena cava filter and for which the catalog and lot numbers are not currently available.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported in the legal brief becker vs.Cordis, after an unknown period of time when a trapease vena cava filter was implanted, the filter subsequently malfunctioned and caused injury and damages to plaintiff including, but not limited to, blood clots, clotting and occlusion of ivc filter.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.The trapease filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Vena cava thrombus in the filter does not represent a device malfunction.The reported vena cava thrombosis could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
 
Event Description
As reported in the legal brief becker vs.Cordis, after an unknown period of time when a trapease vena cava filter was implanted, the filter subsequently malfunctioned and caused injury and damages to plaintiff including, but not limited to, blood clots, clotting and occlusion of ivc filter.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.
 
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Brand Name
TRAPEASE FILTER
Type of Device
THROMBECTOMY SYSTEMS (DQO)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5692803
MDR Text Key46360411
Report Number9616099-2016-00294
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2016
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? No
Device Operator Health Professional
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/09/2016
Initial Date FDA Received06/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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