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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306AU
Device Problem Failure to Align (2522)
Patient Problem Injury (2348)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, tilting of the filter.The filter remains implanted; thus, unavailable for analysis.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 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 procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Clinical factors that may have influenced the event include patient, lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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, tilting of the filter.
 
Manufacturer Narrative
Additional information: section d11 (concomitant medical products: cordis.035" pfte fc 3mm j {wire} 150cm, merit.Stittened 10cm {sheath} 4 fr, 21-gauge micropuncture set, 68cm dilator, sheath and canula).Complaint conclusion: previous code of tilt, new code of anxiety.It was reported that a patient underwent placement of a trapease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused tilting of the filter.The patient reported becoming aware of filter tilt approximately eight years and five months post implant.The patient also reported experiencing anxiety.According to the implant record the indication for the filter implant was massive pulmonary embolism and recurrent deep vein thrombosis.Additional patient history was noted as morbid obesity, type ii diabetes and generalized osteoarthritis.The filter was placed via the right femoral vein and deployed below the level of the renal veins.The patient tolerated the procedure well.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 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 procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry, technique and tortuosity.Without procedural films or images for review the reported event(s) could not be confirmed.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information available for review at this time, 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, tilting of the filter.The following additional information was received per medical records: the patient presented with massive pulmonary embolism, recurrent dvt, is morbidly obese, type ii diabetic mellitus and has generalized osteoarthritis.The patient was on 02, had a left nasal cannula and sat greater than 94%.The right femoral vein was accessed and cannulated via right groin and an inferior vena cavogram was performed.The trapease ivc filter was deployed in optimal position below the renal veins and the procedure was completed without complication.The patient was said to tolerate the procedure well and transported in stable condition to telemetry bed.The following additional information was received per patient profile form (ppf): the patient became aware of the reported events approximately 8 years and 5 months post implantation.The patient reports filter tilt.The patient also reports suffering from anxiety.
 
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Brand Name
TRAPEASE PVCF FEM/JUG 55CM CSI
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
MDR Report Key9897988
MDR Text Key188518673
Report Number1016427-2020-03971
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 other
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2013
Device Model Number466P306AU
Device Catalogue Number466P306AU
Device Lot Number15285442
Was Device Available for Evaluation? No
Date Manufacturer Received05/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age60 YR
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