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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Edema (1820); Occlusion (1984); Perforation (2001); Renal Failure (2041); Thrombosis (2100); Urinary Retention (2119); Perforation of Vessels (2135)
Event Date 05/12/2018
Event Type  Injury  
Manufacturer Narrative
As reported, the patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis (dvt), pulmonary embolism (pe) and filter perforation. As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment. As further proximate results, the patient has suffered and will continue to suffer significant medical expenses, pain, and suffering, and other damages. The device was 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). 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. Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such. Without procedural films available for review, the reported perforation could not be confirmed. With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined. The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. 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 trapease vena cava filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis ( dvt), pulmonary embolism (pe) and filter perforation. As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment. As a further proximate results, the patient has suffered and will continue to suffer significant medical expenses, pain, and suffering, and other damages.
 
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Brand Name466P306X
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 Key7580481
MDR Text Key110447642
Report Number1016427-2018-01523
Device Sequence Number1
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,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466P306X
Device Lot NumberUNKNOWN
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 Received08/16/2019
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: 06/07/2018 Patient Sequence Number: 1
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