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U.S. Department of Health and Human Services

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

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CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306X
Device Problems Filter (816); Bent (1059); Kinked (1339); Difficult to Remove (1528); Failure to Align (2522)
Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572); No Code Available (3191)
Event Date 04/15/2011
Event Type  Injury  
Manufacturer Narrative

The exact implant date is not known but the filter was implanted on or about (b)(6) 2003. As reported, the patient underwent a surgical procedure to implant a trapease inferior vena cava (ivc) filter for the treatment of deep venous thrombosis. The device was implanted into the renal veins by the physician. The device in the patient was positively identified by the patients¿ medical records. Approximately eight years, three months post implant, the patient received an exam on his abdomen and pelvis which showed extensive ivc thrombosis, the ivc filter was also noted in the medical records as bent and tilted with calcification. Approximately five days later, the patient received an exam on his abdomen and pelvis at which showed that the ivc filter appeared seated within the vena cava, a clot in the center and extends into the bilateral common iliac veins as well as into the left external iliac, left common femoral, left superficial veins. As a result of the malfunctioned trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. The trapease 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. Blood clots and occlusion of the ivc filter does not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Calcification is the accumulation of calcium salts in a body tissue. It is transported through the blood stream. Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden. Calcification within a patient does not represent a device malfunction. Without images or procedural films for review, the reported filter tilt and bent condition could not be confirmed and the exact cause could not be determined. Additionally, the timing and mechanism of the reported filter tilt is unknown. Patient, technique or procedural factors may have contributed to the reported tilt given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or 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 by the legal brief, the patient underwent a surgical procedure to implant a trapease¿ filter for the treatment for deep venous thrombosis. The device was implanted into the renal veins by the physician. The device in the patient was positively identified by the patients¿ medical records. Approximately eight years, three months post implant the patient received an exam on his abdomen and pelvis which showed extensive inferior vena cava (ivc) thrombosis, his ivc filter was noted in the medical records as bent and tilted with calcification. Approximately five days later the patient received an exam on his abdomen and pelvis at which showed that the inferior vena cava (ivc) filter appeared seated within the vena cava with a clot in the center and extends into bilateral common iliac veins as well as into the left external iliac, left common femoral, left superficial veins. As a result of the malfunction of the malfunctioned trapease¿ filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.

 
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Brand NameUNKNOWN TRAPEASE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6980890
MDR Text Key90392581
Report Number1016427-2017-00711
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466P306X
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 Received05/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/26/2017 Patient Sequence Number: 1
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