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

Catalog Number 466P306X

Device Problem Defective Component (2292)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter was associated with deep vein thrombosis (dvt) and caval thrombosis.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 inferior vena cava (ivc) 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 that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.These events do not represent a malfunction of the device.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Given the limited information available for review, there is nothing to suggest that 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.

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 deep vein thrombosis and caval thrombosis.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, and 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, b7, d11, g3, g4, g7, h1, h2 and h6.Section b5: additional information received per the medical records indicate that the patient has a history of deep vein thrombosis, pulmonary embolus and has some hemoptysis from anticoagulation.The filter was deployed via the patient's right jugular.It was placed in the infrarenal area.  additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events approximately ten years after the index procedure.The patient has also experienced worry, anxiety and fear.The patient continues to experience psychological, mental anguish and painful ulcers on the lower portions of both legs.The form notes that the ulcers continue for months and some do not heal completely.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 deep vein and caval thrombosis.According to the patient profile form the patient became aware of blood clots, clotting and/or occlusion of the inferior vena cava (ivc), approximately ten years after the index procedure.The patient also reports worry, anxiety, fear and painful ulcers on the lower portions of both legs.The form notes that the ulcers continue for months and some do not heal completely.The indication for the filter implant was deep vein thrombosis (dvt) and pulmonary embolus (pe) and has had some hemoptysis from anticoagulation.The filter was placed via the right internal jugular vein and deployed infrarenally.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.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/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Ivc filters are not indicated for use in the prevention of dvt.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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 swelling of the affected extremity and ultimately ulcerations.Leg ulcers and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided the reported event(s) could not be confirmed or further clarified nor a determination as to the caused be established.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: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 9485057
• MDR Text Key: 176936323
• Report Number: 1016427-2019-03682
• Device Sequence Number: 1
• Product Code: DTK
• 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: 01/30/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/30/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR