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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
Model Number 466P306X
Device Problem Break (1069)
Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135); No Code Available (3191)
Event Date 08/10/2017
Event Type  Injury  
Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter. The indication for the filter placement was not reported. At some point after the filter implantation, the patient reported having experienced deep vein thrombosis (dvt), post-thrombotic syndrome, chest pain, shortness of breath and perforation of the inferior vena cava (ivc). 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 ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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. Without images or procedural films for review, the reported ivc perforation could not be confirmed and the exact cause could not be determined. A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation. Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt. A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh. Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency. Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis). There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis. These events do not represent a malfunction of the device. Post-thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis. Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency. Due to the nature of the complaint, the reported chest pain and shortness of breath experienced by the patient could not be confirmed and the exact cause could not be determined. These clinical events do not represent evidence of a device malfunction. Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics. Given the limited information available for review, there is nothing to suggest that a malfunction in 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, deep vein thrombosis (dvt) post-thrombotic syndrome, chest pain, shortness of breath and inferior vena cava (ivc) perforation. 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 and suffering and other damages.

 
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Brand NameUNKNOWN TRAPEASE
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
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 Key10391641
MDR Text Key202408447
Report Number1016427-2020-04269
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,Followup
Report Date 09/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device MODEL Number466P306X
Device Catalogue Number466P306AU
Device LOT Number17419669
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/02/2016
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: 08/11/2020 Patient Sequence Number: 1
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