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

Model Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Obstruction/Occlusion (2422)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.(b)(4).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 pulmonary embolism (pe) and tilt.The patient reported becoming aware of filter tilt, blood clots, clotting and/or occlusion of the inferior vena cava, approximately fifteen years post implant.The patient also reported anxiety, depression, filter clogging and discomfort.According to the medical records the indication for the filter implant was pulmonary embolism and recurrent deep vein thrombosis of the lower extremities despite therapeutic anticoagulation therapy.The filter was placed via the right internal jugular vein and deployed below the renal veins and appeared to be well aligned.The procedure was well tolerated.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient, vessel characteristics and pharmacological factors may have contributed to these events.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.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.Please note that this is the initial report for this product.

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 pulmonary embolism (pe) and tilt.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, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient has a history of pulmonary embolism, recurrent deep vein thrombosis of the lower extremities despite therapeutic anticoagulation therapy.The filter was deployed via the patient's right internal jugular vein.The filter was placed below the renal veins and appeared to be well aligned.The procedure was well tolerated.  additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, blood clots, clotting and/or occlusion of the inferior vena cava.The patient became aware of the reported events approximately fifteen years after the index procedure.The patient has also experienced anxiety, depression, filter clogging and discomfort.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12264602
• MDR Text Key: 264825648
• Report Number: 1016427-2021-05228
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0305225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Date Device Manufactured: 03/16/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TRAPEASE INTRODUCER SET; UNKNOWN 0.018 INCH GUIDE WIRE; UNKNOWN 0.035 INCH GUIDE WIRE; UNKNOWN 21-GAUGE NEEDLE; UNKNOWN MICROPUNCTURE SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 42 YR