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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 Partial Blockage (1065)
Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation. It was reported that a patient underwent placement of an unspecified vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused deep vein thrombosis (dvt). The patient reported becoming aware of blood clots (nine, left leg), clotting and/or occlusion of the inferior vena cava (ivc), approximately seventeen years post implant. The patient also reported pain in leg and body pain (left side). The indication for the filter implant, procedural details and medical history of the patient have 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 cordis vena cava filters are 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. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt). Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency. Ivc filters are not indicated for use in the prevention of dvt. Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics. Pain does not represent a device malfunction and may be related to underlying patient specific issues. Given the limited information currently available for review, 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. Please note that this is the initial report for this product.
 
Event Description
As reported by the legal brief, the patient underwent placement of an unidentified cordis vena cava filter. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis (dvt). As a direct and proximate result of these malfunctions, 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 continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information received per the patient profile form (ppf) states that the patient experienced blood clots (nine, left leg), clotting and/or occlusion of the inferior vena cava( ivc). The patient became aware of the reported events approximately seventeen years after the index procedure. The patient has also experienced pain in leg and body pain (left side).
 
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Brand NameUNKNOWN TRAPEASE
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key12264591
MDR Text Key264705100
Report Number1016427-2021-05227
Device Sequence Number1
Product Code DTK
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 company representative,other
Reporter Occupation
Type of Report Initial
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/02/2021 Patient Sequence Number: 1
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