• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CASHEL UNKNOWN TRAPEASE FILTER CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 466P306X
Device Problem Failure to Align (2522)
Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100)
Event Date 02/15/2016
Event Type  Injury  
Manufacturer Narrative
As reported, the 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: caval thrombosis, deep vein thrombosis (dvt) and tilt of the ivc filter. As a direct and proximate result of these malfunctions the patient suffered life-threatening injuries and 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 devices were not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. 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. Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt). Deep vein thrombosis (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. Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis). Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency. Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities. The presence of these clots do not represent a device malfunction. There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis. Without images or 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. Additionally, the timing and mechanism of the reported filter tilt is unknown. Patient, technique or procedural factors may have contributed to the reported tilt. Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to: caval thrombosis, deep vein thrombosis (dvt) and tilt of the ivc filter. As a direct and proximate result of these malfunctions the patient suffered life-threatening injuries and 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN TRAPEASE 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 Key8371372
MDR Text Key137232356
Report Number1016427-2019-02558
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 05/09/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received04/12/2019
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: 02/26/2019 Patient Sequence Number: 1
-
-