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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 Migration (4003)
Patient Problem Injury (2348)
Event Date 05/08/2019
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had migrated.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.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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 filter migration could not be confirmed and the exact cause could not be determined.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 include 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 ivc 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.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to migration.
 
Manufacturer Narrative
According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately twelve years and four months post implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, migration of entire filter other than to heart.The patient also reports anxiety and worry.The following additional information received per the medical records state that the patient has a medical history of extensive pulmonary emboli.During the implant procedure, the right groin was accessed and the filter was placed at the level of the renal veins.No immediate complications occurred.
 
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 migration.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately twelve years and four months post implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, migration of entire filter other than to heart.The patient also reports anxiety and worry.The following additional information received per the medical records state that the patient has a medical history of extensive pulmonary emboli.During the implant procedure, the right groin was accessed and the filter was placed at the level of the renal veins.No immediate complications occurred.
 
Manufacturer Narrative
As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of extensive pulmonary emboli (pe).The indication for the emergent filter placement was reported to be blood clots.The filter was implanted via the right groin and placed at the level of the renal veins without immediate complications.More than twelve years after the filter implantation, the patient became aware that the filter had migrated.The patient further reported having experienced mental anguish, anxiety and worry associated with 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 pe via percutaneous placement in the inferior vena cava (ivc) 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 filter migration could not be confirmed and the exact cause could not be determined.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 include 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 ivc 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 anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.
 
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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 
MDR Report Key9485345
MDR Text Key176935048
Report Number1016427-2019-03691
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 03/30/2020
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? Yes
Device Operator Health Professional
Device Catalogue Number466P306AU
Device Lot NumberR1108412
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/17/2019
Supplement Dates Manufacturer Received02/05/2020
03/26/2020
Supplement Dates FDA Received03/08/2020
03/30/2020
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age54 YR
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