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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER CATHETER, INTRAVASCULAR, DIAGNOSTIC

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CORDIS CASHEL UNKNOWN VENA CAVA FILTER CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number UNKFILTER
Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522)
Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
As reported, the patient underwent placement of an unknown vena cava filter. The filter subsequently malfunctioned and caused injury and damage, including, but not limited to thrombosis in the inferior vena cava (ivc), tilt and perforation of the ivc filter struts through the ivc wall. 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. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed. The 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 presence of a thrombosis in a vessel does not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. The timing and mechanism of the tilt has not been reported at this time. The brief also reported perforation of the inferior vena cava; however, a clinical conclusion could not be determined as to the cause of the event. It is unknown if the tilt contributed to the reported perforation. A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. However, 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 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 placement of an unknown vena cava filter. The filter subsequently malfunctioned and caused injury and damage, including, but not limited to thrombosis in the inferior vena cava (ivc), tilt and perforation of the ivc filter struts through the ivc wall. 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.
 
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Brand NameUNKNOWN VENA CAVA FILTER
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
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 Key8343128
MDR Text Key136254163
Report Number9616099-2019-02713
Device Sequence Number0
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/02/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKFILTER
Device Lot NumberUNKNOWN
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 Received04/12/2019
Was Device Evaluated by Manufacturer? No
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: 02/15/2019 Patient Sequence Number: 1
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