• 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 466P306AU FILTER, INTRAVASCULAR, CARDIOVASCULAR

  • 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 466P306AU FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306AU
Device Problems Filter (816); Retraction Problem (1536)
Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)
Event Date 05/04/2018
Event Type  Injury  
Manufacturer Narrative

As reported, the patient underwent placement of the trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed. 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, and pain and suffering, and other damages. The product was not returned for analysis. Additionally, as the sterile lot number was not available, a 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. 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). Factors that may have influenced the event include patient, pharmacological and lesion. There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis. The cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter. Six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall. Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling, including being crushed. The off label use of this filter likely contributed to the retrieval difficulty experienced by the customer. 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 team, the patient underwent placement of the trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed. 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, and pain and suffering, and other damages.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name466P306AU
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
IS 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7550848
MDR Text Key109457132
Report Number1016427-2018-01498
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2015
Device MODEL Number466P306AU
Device Catalogue Number466P306AU
Device LOT Number15657217
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/07/2018
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/30/2012
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: 05/29/2018 Patient Sequence Number: 1
-
-