MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; THROMBECTOMY SYSTEMS

Model Number N/A

Device Problems Occlusion Within Device (1423); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Cellulitis (1768); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); No Code Available (3191)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

There is no patient code available for the following events: lymphedema and wounds.Please note that a previous regulatory report was submitted under manufacturing report number 9616099-2016-00236.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported in the legal brief, the patient underwent placement of a trap ease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, thrombosis of the inferior vena cava.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.Additional information was received from the patient profile form that the filter has tilted, embedded in the wall of the ivc, there are blot clots, clotting and occlusion of the ivc which is unable to be retrieved.There have been no attempts made to remove the device.The patient believes the device has caused severe pain and suffering and mental anguish.These injuries include occlusion of my vena cava, peripheral edema, severe pain, varicose veins, venous insufficiency, lymphedema, cellulitis and wounds on the feet, ankles and legs, and a substantially reduced ability to enjoy life or work.Because of all of the above issues the patient homebound most of the time and must keep the feet and legs elevated as much as possible.It¿s become a daily struggle to mentally muscle through all of the negative thoughts and feeling he suffer through as he sees little or no positive outcome.Add this to the fact that the filter cannot be removed without a high percentage chance of dying the patient finds that sometimes he simply cries because he sees no hope.He is also affected by the fact that he is no longer able to enjoy a normal relationship with a companion as he is unable to function.Additional information received in medical records indicate that prior to filter placement, the patient had recurrent left lower extremity deep venous thrombosis, decompensated cor pulmonale, possible new pulmonary embolism, chronic central pulmonary emboli with frank pulmonary hypertension, chronic pulmonary hypertension, chronic atrial fibrillation, right atrial thrombus, depression, medical noncompliance with anti-coagulation therapy, therefore, filter placement was recommended.

Manufacturer Narrative

As reported in the legal brief, the patient underwent placement of a trap ease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, thrombosis of the inferior vena cava.Additional information was received from the patient profile form that the filter has tilted, embedded in the wall of the ivc, there are blot clots, clotting and occlusion of the ivc which is unable to be retrieved.There have been no attempts made to remove the device.The patient believes the device has caused severe pain and suffering and mental anguish.According to the patient ¿these injuries include occlusion of my vena cava, peripheral edema, severe pain, varicose veins, venous insufficiency, lymphedema, cellulitis and wounds on the feet, ankles and legs, and a substantially reduced ability to enjoy life or work.Because of all of the above issues the patient homebound most of the time and must keep the feet and legs elevated as much as possible.It¿s become a daily struggle to mentally muscle through all of the negative thoughts and feeling he suffer through as he sees little or no positive outcome.Add this to the fact that the filter cannot be removed without a high percentage chance of dying the patient finds that sometimes he simply cries because he sees no hope.He is also affected by the fact that he is no longer able to enjoy a normal relationship with a companion as he is unable to function.¿ the patient¿s medical history is significant for chronic atrial fibrillation, chronic cigarette smoking, bilateral deep vein thrombosis (dvt), bilateral pulmonary embolism (pe), right atrial mass consistent with right atrial thrombosis, sleep apnea, bilateral ankle edema (seven years prior to filter placement), more significantly lower extremity edema (two years prior to filter implant).Psychosocial history of giving up hope on life due to some major financial problems related to some wrong business decision and has since not been taking digoxin and coumadin regularly.The patient also reported a twenty-five-pound weight gain in the past three weeks and complains of constipation.Physical assessment of the lower extremities, noted upon admission, indicated 1+ pre-tibial edema of both extremities and 2+ pitting edema of both ankles.Diagnostic imaging revealed: chest x-ray; pulmonary hypertension.Venous ultrasound; old right superficial femoral vein thrombosis, thrombus in the left superficial femoral vein, popliteal and trifurcations veins which was considered a complication of old and new thrombus.Echocardiogram; right sided heart failure, echodensity in the right atrium consistent with thrombus, also noted in previous study from two years prior.The indication for the filter implant was a concern for bilateral thrombi in both the left and right pulmonary arterial system.Review of the pulmonary clots and recent recurrent dvt, as well as pulmonary hypertension, it was felt that the patient was at high risk from any potential complications associated with the current pe¿s, therefore ivc was recommended.Consideration was also given to the possible feasibility of a pulmonary artery thrombectomy.Procedural details have not been provided and there is currently no additional information available for review.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 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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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 reported filter tilt and device embedded could not be confirmed or clarified and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.With the limited information provided and no post implant imaging available for review it is not possible to establish a relationship between the reported events and the device.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.Clotting and device occlusion related to clotting and embedded in the wall do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in edema.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.Anxiety, peripheral edema, varicose veins, pain, venous insufficiency, lymphedema, cellulitis, and wounds on the lower extremities do not represent a device malfunction and may be related to underlying patient specific issues, primarily pre-existing medical conditions.Given the limited information available for review, there is nothing to suggest that there is 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7443154
• MDR Text Key: 105916612
• Report Number: 9616099-2018-02064
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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: N/A
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0305627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/20/2018
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR