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

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

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 tilt.The indication for the filter placement, procedural details and medical history have not been provided and there is no additional information available for review.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.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.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 by the legal team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to tilt.As a direct and proximate result, 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 suffer significant expenses, pain, and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.

Event Description

Additional information received per the medical records indicate that the patient has a history of bilateral pulmonary embolism, deep vein thrombosis with recurrent hemoptysis and is not a candidate for anticoagulation with coumadin.The filter was implanted via the patient's right common femoral vein.The filter was deployed below the renal veins and above the iliac bifurcation.No complications were noted.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 (ivc).The patient became aware of the reported events approximately twelve years and seven months after the index procedure.

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 tilt.The patient reported becoming aware of filter tilt, blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), approximately twelve years and seven months post implant.According to the medical record indication for the filter placement was bilateral pulmonary embolism with a history of deep vein thrombosis with recurrent hemoptysis and not a candidate for anticoagulation with coumadin.The filter was placed via the right common femoral vein and was deployed below the renal veins and above the iliac bifurcation.No complications were noted.The product remains implanted and unavailable 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.Blood clots, clotting, and occlusion of the device or vasculature does not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient 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.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13226725
• MDR Text Key: 283612185
• Report Number: 9616099-2022-05285
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2022

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 Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0608551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 09/22/2022
• Supplement Dates FDA Received: 09/20/2022; 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male