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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306X
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/20/2021
Event Type  Injury  
Manufacturer Narrative

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 tilting. The indication for the filter implant has not been provided and there is currently 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. Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, 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

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter tilting. As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will suffer significant medical expenses, pain, suffering and other damages.

 
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Brand NameUNKNOWN TRAPEASE
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014-2802
7863138372
MDR Report Key12326423
MDR Text Key266841594
Report Number1016427-2021-05291
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
Type of Report Initial
Report Date 08/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466P306X
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 08/16/2021 Patient Sequence Number: 1
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