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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
Catalog Number 466P306AU
Device Problem Material Perforation (2205)
Patient Problem Perforation of Vessels (2135)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation that causes injury and damage to the patient.Per the implant records, the patient was status post a massive pulmonary embolus, intubated and on ventilatory support.The inferior vena cava (ivc) filter placement was indicated as the patient would not tolerate anticoagulation due to a significant recent bleed.The right femoral vein was accessed, and using fluoroscopy guidance, the filter was deployed below the renal veins at the level of the vertebral lumbar body, l2 and l3.The patient tolerated the procedure well and was transported in stable condition to the recovery room.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years post implant.The patient reports perforation of filter strut(s) outside the inferior vena cava (ivc).The patient further experienced anxiety related to the filter.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported perforation could not be confirmed, and the exact causes could not be determined.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, there is nothing to suggest that the reported events are 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 in the legal brief, a 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, perforation that causes injury and damage to the patient.Per the implant records, the patient was status post a massive pulmonary embolus, intubated and on ventilatory support.The inferior vena cava (ivc) filter placement was indicated as the patient would not tolerate anticoagulation due to a significant recent bleed.The right femoral vein was accessed, and using fluoroscopy guidance, the filter was deployed below the renal veins at the level of the vertebral lumbar body, l2 and l3.The patient tolerated the procedure well and was transported in stable condition to the recovery room.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years post implantation.The patient reports perforation of filter strut(s) outside the inferior vena cava (ivc).The patient further experienced anxiety related to the filter.
 
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Brand Name
TRAPEASE PVCF FEM/JUG 55CM CSI
Type of Device
FILTER, 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 Key9382719
MDR Text Key168575033
Report Number1016427-2019-03603
Device Sequence Number1
Product Code DTK
UDI-Device Identifier20705032009451
UDI-Public20705032009451
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 other
Reporter Occupation Other
Type of Report Initial
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2013
Device Catalogue Number466P306AU
Device Lot Number15246128
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/05/2019
Initial Date FDA Received11/27/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/28/2011
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) Life Threatening;
Patient Age81 YR
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