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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 Problems Death (1802); Occlusion (1984); Perforation (2001); Thrombosis (2100)
Event Date 07/29/2020
Event Type  Death  
Manufacturer Narrative

Please note that device reported is atrapease vena cava filter and for which the catalog and lot numbers are not currently available. The device remains implanted and is not available for evaluation. Patient age and medical history were also not provided. If obtained, a follow up report will be submitted within 30 days upon receipt. The patient is reported to have died but the exact date has not been provided. Please note that the contact is not a medical professional but a more accurate choice is not available. As reported, the patient was implanted with a trapease inferior vena cava (ivc) filter. The indication for filter placement is not available. The filter subsequently malfunctioned and caused injury, damage, and/or wrongful death the patient, including, but not limited to caval stenosis, caval thrombosis, ivc perforation, filter tilt & embedment. The filter remains implanted; thus, unavailable for analysis. 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. Without procedural films for review, the filter tilt reported could not be confirmed. Additionally, the timing and mechanism of the filter tilt is unknown. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction. A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive). Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli. Permanent ivc filters have been reported to obstruct in up to 20% of patients. The predominant concern for embedding with in the wall of the ivc is the development of endothelialization. Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells. This is the normal process whereby the body heals and recovers from invasive procedures. Endothelialization has been shown to occur in as short a period as 12 days. It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event. A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place. 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films or images for review the reported event(s) could not be confirmed. 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

A patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused injury, damage, and/or wrongful death the patient, including, but not limited to caval stenosis, caval thrombosis, ivc perforation, filter tilt & embedment. As a direct & proximate result, the patient suffered life-threatening injuries & damages & required extensive medical care & treatment. As a further proximate. Result, the patient has suffered & will suffer significant medical expenses, pain & suffering & 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 Key10436821
MDR Text Key203842186
Report Number1016427-2020-04294
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 08/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2020
Is This An Adverse Event 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 Received08/07/2020
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: 08/21/2020 Patient Sequence Number: 1
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