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U.S. Department of Health and Human Services

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

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CORDIS CASHEL UNKNOWN TRAPEASE FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number UNKFILTER
Device Problem Difficult to Remove (1528)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Bradycardia (1751); Death (1802); Edema (1820); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263); Injury (2348)
Event Date 06/13/2017
Event Type  Death  
Manufacturer Narrative

It was reported that a patient was implanted with an unknown inferior vena cava (ivc) filter. The information provided indicated that the at approximately twelve years and eleven months post implant, the patient had a chronic indwelling ivc filter and presented for ivc filter retrieval. A computerized tomography (ct) scan showed the filter embedded and penetrating through ivc wall in addition to left iliac vein stenosis. Removal of the filter was attempted but not successfully, as the filter was infrarenal in location and appeared embedded with struts penetrating laterally. It was also noted that the filter was unable to be completely retracted likely reflecting non retracted struts, and complicated by caval injury, resulting in failure to safely remove the filter and patient death. The medical records for the filter placement, retrieval attempt and a death certificate have not been provided. 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. An inferior 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. The predominant concern after implant, is the development of endothelialization, which would make subsequent removal difficult. Endothelialization has been shown to lead to explant problems after as short a period as 12 days. A review of the instructions for use notes vessel damage such as intimal tears and perforation as a long-term and a procedural complication associated with ivc filters, however a positive product identification has not been provided. Left iliac stenosis does not represent a device malfunction and may be related to underlying patient specific issues. Caval injury was reported, with the limited information provided it is not possible to make a clinical determination as to the exact cause of the event, however, procedural factors may have contributed to the event. As a death certificate has not been provided a c relationship between the device and the event cannot be established. 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.

 
Event Description

As reported in the legal brief, a patient was implanted with an unknown inferior vena cava (ivc) filter. The patient and the patient¿s physicians used the ivc filter as intended. Approximately twelve years and eleven months after the filter was implanted, the patient had a chronic indwelling ivc filter and presented for ivc filter retrieval. A computerized tomography (ct) scan showed the filter embedded and penetrating through ivc wall. There was a left iliac vein stenosis noted on the ct scan. Removal of the filter was attempted but not successfully, as the filter was infrarenal in location and appeared embedded with struts penetrating laterally. It was also noted that the filter was unable to be completely retracted likely reflecting non retracted struts, and complicated by caval injury, resulting in failure to safely remove the filter and patient death. The decedent¿s daughter suffered mental pain and suffering as a direct and proximate result of the decedent¿s injury and death.

 
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Brand NameUNKNOWN TRAPEASE 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
7863138372
MDR Report Key9610970
MDR Text Key175677901
Report Number9616099-2020-03492
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
Report Date 12/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKFILTER
Device Catalogue NumberUNKFILTER
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 Received12/01/2020
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: 01/21/2020 Patient Sequence Number: 1
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