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U.S. Department of Health and Human Services

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

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CORDIS CASHEL UNKNOWN TRAPEASE FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 466P306X
Device Problem Migration (4003)
Patient Problems Chest Pain (1776); Death (1802); Dyspnea (1816); Nausea (1970); Vomiting (2144); Weakness (2145); Dizziness (2194); Sweating (2444)
Event Date 02/18/2015
Event Type  Death  
Manufacturer Narrative
As reported, the patient underwent placement of a trapease filter in the inferior vena cava.Approximately fifteen days after the procedure, the patient began complaining of chest pains.The symptoms included nausea, vomiting, sweating, difficulty breathing, cough, weakness and dizziness.On the day these symptoms began, on route to doctors office, the patient became unresponsive while still in the car.The patient was rerouted to the emergency department where advanced cardiac life support was begun.Unfortunately, the patient was unable to be revived and expired that day, as a result of the defective trapease filter and its migration from the inferior vena cava to the heart.Per the briefing, after an autopsy was conducted, the trapease device was discovered in the right ventricle of the patients¿ heart.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.An inferior vena cava (ivc) 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.Without medical records/autopsy report available for review, the reported migration of the ivc filter to the heart is unable to be confirmed.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.The events reported that the patient experienced may be cardiac related and without medical records available the clinical cause is unable to be conclusively determined.The untimely expiration of the patient is unfortunate, 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 a trapease filter implanted in the inferior vena cava.Approximately fifteen days after the patient began complaining of chest pains.The symptoms included nausea, vomiting, sweating, difficulty breathing, cough, weakness and dizziness.The patient went on the same day to the general physician.However, the patient became unresponsive while still in the car.The patient was rerouted to the emergency department where advanced cardiac life support was instituted.The patient was unable to be revived and died on that day, as a result of the defective trapease filter and its migration from the inferior vena cava to the heart.Per the briefing, after an autopsy was conducted, the trapease device was discovered in the right ventricle of the patients¿ heart.
 
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Brand Name
UNKNOWN TRAPEASE FILTER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
33152
EI   33152
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key7731062
MDR Text Key115365886
Report Number1016427-2018-01702
Device Sequence Number1
Product Code DQO
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 Other Health Care Professional
Type of Report Initial
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2018
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 Sequence Number1
Patient Outcome(s) Death;
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