MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Embolism (1829); Occlusion (1984); Thrombosis (2100)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date in the report is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots, clotting or occlusion of the ivc, migration, pulmonary embolism (pe) and thrombosis/embolism.The patient suffered life-threatening injuries and damages, requiring 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.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The inferior 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 available for review, it is not possible to clarify the location (proximal or distal) of the clots to the location of the ivc filter.Blood clots and thrombosis/embolism do not represent a device malfunction.Placement of a vena cava filter is not a cure for blood clots nor does it prevent the formation of other clots (thrombosis/embolism).Inferior vena cava (ivc) filter migration is a known potential event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.Given the limited information available for review at this time, 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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots, clotting or occlusion of the ivc, migration, pulmonary embolism (pe) and thrombosis/embolism.The patient suffered life-threatening injuries and damages, requiring 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.No additional information is available.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.Additional information received per the medical records indicate that the patient has a history of a deep vein thrombosis, large pulmonary embolism, cold left foot, right knee septic arthritis with respiratory distress, right side common femoral vein thrombosis, right side superficial femoral vein thrombosis, knee pain, knee swelling, hypertension and high lipids.Two days after the index procedure the filter was removed from the patient's right ventricle.The patient had a right atrial intracardiac thrombus.Additional information received per the patient profile form (ppf) states that the previously reported events started the day after the index procedure.On the second day after implantation, the device was removed via an open chest procedure.The patient also experienced emotion distress, mental anguish, anxiety and stress.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 injury, damage, to the patient, including, but not limited to: blood clots, clotting or occlusion of the ivc, migration, pulmonary embolism (pe) and thrombosis/embolism and required open chest removal of the filter.The patient also reported to have experienced emotional distress, mental anguish, anxiety and stress.The patient¿s history consisted of hypertension, osteoarthritis, peptic ulcer disease and hyperlipdemia.The patient initially presented to the hospital with pain and swelling of the right knee and was diagnosed with septic arthritis.Two days later the leg was still hurting, venous duplex ultrasound revealed deep vein thrombosis (dvt) of both the right or left common and superficial femoral veins, the indication for the filter implant.The medical records provide conflicting details as to whether it was the right, or the left leg affected with dvt.The right knee was debrided and irrigated the same day.The following day the patient became sweaty, nauseous and tachycardic, hypotensive and hypoxic while eating breakfast.A ventilation scan was performed and showed moderate to large pulmonary perfusion deficits implying high probability for pulmonary embolism (pe).An echocardiogram was performed which revealed a mass in the right atrium and one in the left atrium, across the tricuspid and mitral valves respectively.The patient was noted to have heparin induced thrombocytopenia.The patient was transferred to another hospital where an open chest pulmonary embolectomy, removal of ivc filter from the right ventricle and tricuspid valve annuloplasty.After surgery the patient was noted to have a left lower extremity cool foot, noted to most likely be an embolic event.No intervention was indicated at the time.The post-operative phase was otherwise unremarkable, and the patient was discharged home approximately thirteen days later.Three days after discharge the patient was seen for right upper extremity swelling that started two days prior and was initially relieved by elevation.Over the course of the next two days the swelling continued and elevation was not providing relief.There is currently 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.A 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.Following implant, 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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Pulmonary embolism is a known long-term complication associated with filter implant and is listed as such in the instructions for use (ifu).Recurrent pe does not indicate a device malfunction.Blood clots and thrombosis within the filter do not represent a device malfunction.Rather, patient and/or pharmacological factors may have contributed to these events.Without the procedural films or notes available for review the reported, migration could not be confirmed, nor could a cause be determined.The sizing of the ivc has not been provided.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7606945
• MDR Text Key: 111243006
• Report Number: 1016427-2018-01534
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/24/2018
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 07/21/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR