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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION UNKNOWN TRAPEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Filter (816); Failure to Align (2522)
Patient Problem Occlusion (1984)
Event Date 07/21/2020
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. Patient age and medical history were also not provided. If obtained, a follow up report will be submitted within 30 days upon receipt. Please note that the contact is not a medical professional but a more accurate choice is not available. It was reported that a patient underwent placement of a trapease vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused filter tilt and stenosis. The indication for the filter placement, procedural details and medical history have not been provided and there is no additional information available for review. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. The trapease vena cava 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. Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity. Without imaging available for review the event could not be confirmed nor a cause attributed. Given the limited information available for review at this time, there is nothing to suggest that the reported events are 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

The filter subsequently malfunctioned and caused injury, damage, and/or wrongful death to plaintiff/decedent, including, but not limited to: there is specific evidence that the filter is tilted and stenosed. As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

 
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Brand NameUNKNOWN TRAPEASE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10369102
MDR Text Key201838918
Report Number1016427-2020-04258
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number466P306X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated By Manufacturer? No
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: 08/05/2020 Patient Sequence Number: 1
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