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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306AU
Device Problem Failure to Align (2522)
Patient Problems Cardiopulmonary Arrest (1765); Myocardial Infarction (1969); Perforation of Vessels (2135)
Event Date 12/15/2017
Event Type  Death  
Manufacturer Narrative

Occupation: other, senior counsel, litigation. Please note that this is the initial report for this product. Additional information is pending and will be submitted within 30 days of receipt.

 
Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter and grade 1 perforation of the inferior vena cava. 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 patient is deceased. No information was provided to relate her demise to the device. The patient is deceased. No information was provided to relate her demise to the device. Information received per the patient profile form (ppf) states that the patient experienced perforation of the filter struts outside the inferior vena cava and abdominal pain from the filter. The patient became aware of the reported events seven years and nine months after the index procedure. Information received per the medical records indicate that the patient has a surgical history of right knee, gastric bypass and l1 compression fracture (whose repair had been postponed at the time of the index procedure). The patient also has a history of cll (chronic lymphocytic leukemia), diabetes mellitus, gastroesophageal reflux disease (gerds), hypertension, pulmonary embolism (pe), deep vein thrombosis (dvt), hyperlipidemia, trigeminal neuralgia, arthritis, svt (supraventricular tachycardia), shortness of breath, palpitations, chest pain, and myocardial infarction possibly from right heart strain from large pe. The filter was implanted with a femoral approach. The patient tolerated the procedure well. Seven years and nine months after the index procedure the patient presented to the emergency room. During a cardiac echogram, the patient passed out when she was rolled on her side. The night before the patient had a 100. 8 degree temperature, shortness of breath, congestion and a cough. The patient denied any other syncopal episodes. The patient had experienced ventricular arrhythmic arrest with spontaneous termination. After the patient was stabilized she was discharged. According to the death certificate, the patient died eight years and three months after the index procedure. The cause of death was cardiopulmonary arrest and an acute myocardial infarction. Contributing factors were diabetes and hypertension. There was no autopsy.

 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
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 Key9527781
MDR Text Key172994434
Report Number1016427-2019-03704
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 02/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2012
Device MODEL Number466P306AU
Device Catalogue Number466P306AU
Device LOT Number15078386
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 Received01/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/19/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/27/2019 Patient Sequence Number: 1
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