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

Model Number 466P306AU

Device Problem Fracture (1260)

Patient Problems Coagulation Disorder (1779); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

As reported by 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, specific evidence that the filter has two fractured struts and there is high grade stenosis of the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient has 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.The device was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿filter-tilt, filter-fractured - in patient and inferior vena cava stenosis¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.However, reports of adverse clinical sequelae from filter fractures are rare.Without images available for review the reported events could not be confirmed or further clarified.As no lot number or other product information was supplied a phr could not be completed.The little information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by 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 specific evidence that the filter has two fractured struts and there is high grade stenosis of the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient has 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of obesity, chronic anxiety, gastroesophageal reflux disease, hypertension, mood disorder, right lung nodule, insomnia, right knee arthroscopy and meniscal repair.The indication for the filter implant was extensive thrombosis of the right popliteal vein, and bilateral pulmonary emboli.The filter was placed via the right internal jugular vein and deployed at the junction of the third and fourth lumbar vertebral bodies above the bifurcation, but below the renal veins.Approximately seven months post implant a follow up bilateral lower extremity (ble) ultrasound (u/s) was performed and showed no evidence of deep vein thrombosis (dvt).Approximately four years and four months post implant a right lower extremity u/s was performed for leg pain and was negative for dvt.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture.The patient became aware of the reported events approximately thirteen years and one month after the index procedure.The patient also reported tiredness, body aches and pains (knees, flank, legs), palpitations, shortness of breath, leg and feet swelling with discoloration of the right leg and foot, bladder incontinence, 95% occlusion of the fractured ivc filter, blood clots in both legs and the abdomen, pain following unspecified surgical procedures, left heel numbness and pain, anxiety, depression, and posttraumatic stress disorder (ptsd) related to the filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: as reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused fracture of 2 filter struts and stenosis.The patient reported becoming aware of filter fracture approximately thirteen years and one month post implant.The patient also reported tiredness, body aches and pains (knees, flank, legs), palpitations, shortness of breath, leg and feet swelling with discoloration of the right leg and foot, bladder incontinence, 95% occlusion of the fractured ivc filter, blood clots in both legs and the abdomen, pain following unspecified surgical procedures, left heel numbness and pain, and posttraumatic stress disorder related to the filter.According to the medical record the patient had a history of obesity, chronic anxiety, gastroesophageal reflux disease, hypertension, mood disorder, right lung nodule, insomnia, right knee arthroscopy and meniscal repair.The indication for the filter was extensive thrombosis of the right popliteal vein, and bilateral pulmonary emboli.The filter was placed via the right internal jugular vein and deployed at the junction of the third and fourth lumbar vertebral bodies above the bifurcation, but below the renal veins.Approximately seven months post implant a follow up bilateral lower extremity (ble) ultrasound (u/s) was performed and showed no evidence of deep vein thrombosis (dvt).Approximately four years and four months post implant a right lower extremity u/s was performed for leg pain and was negative for dvt.The product remains implant and therefore not available 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 ivc 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.Blood clots, clotting, stenosis (abnormal narrowing of a vessel), thrombosis and/or occlusion within the device or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.Shortness of breath, pain, palpitations, being tired and incontinence do not represent a device malfunction and may be related to underlying patient specific issues or comorbidities.There is nothing to suggest that the reported event is related to the design and/or 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 ave; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12259690
• MDR Text Key: 264523447
• Report Number: 1016427-2021-05170
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: R1006216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2006
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR
• Patient Sex: Female