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

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Occlusion (1984); Pain (1994); Thrombosis (2100); Numbness (2415)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but no limited to, blood clots and deep vein thrombosis (dvt).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, pain and suffering, and other damages.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 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.The development of blood clots do not represent a device malfunction.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.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 defendants¿ trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and deep vein thrombosis (dvt).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.Additional information received per the medical records indicate that the patient has a history of bloody stools, invasive duodenal carcinoma, deep vein thrombosis, fatigue, dyspnea, hypertension, tachycardia, coronary artery disease, acute bilateral pulmonary embolism, chronic back pain, arthralgia, bilateral knee replacement surgery, cardia ablation, decreased range of motion in neck and back and secondary malignancy of axillary/upper limb nodes.Prior to the index procedure, the patient was in a hypercoagulable state and had acute deep vein thrombosis of the right peroneal vein.The filter was deployed via the right femoral vein.It was placed below the renal vein.The patient tolerated the procedure well and was in stable condition postoperatively.According to the patient profile form (ppf) the patient experienced occlusion of the inferior vena cava.The patient's legs and feet were in pain, felt like they were numb, they tingled and felt asleep/numb.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported, a patient underwent placement of an trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, occlusion of the inferior vena cava (ivc) and deep vein thrombosis (dvt).The patient is also reported to have experienced pain in the legs and feet, with a feeling of numbness and tingling.The medical records indicated that the patient has a history of bloody stools, invasive duodenal carcinoma, deep vein thrombosis, fatigue, dyspnea, hypertension, tachycardia, coronary artery disease, acute bilateral pulmonary embolism, chronic back pain, arthralgia, bilateral knee replacement surgery, cardia ablation, decreased range of motion in neck and back and secondary malignancy of axillary/upper limb nodes.Prior to the index procedure, the patient was in a hypercoagulable state and had acute deep vein thrombosis of the right peroneal vein and pulmonary embolism.The filter was deployed via the right femoral vein and placed below the renal vein.The patient tolerated the procedure well and was in stable condition postoperatively.The product was not returned for analysis and the sterile lot number provided is invalid; therefore, no device analysis nor device history record review could be performed.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.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.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.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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.Filter occlusion is known long term complications associated with filter implant and are listed as such in the instructions for use (ifu).Clotting, deep vein thrombosis, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and a device malfunction could not be confirmed.Pain and numbness of the lower extremities do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such 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: 7391580
• MDR Text Key: 104145563
• Report Number: 1016427-2018-01333
• 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,Followup
• Report Date: 07/03/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 05/04/2018; 06/10/2018
• Supplement Dates FDA Received: 05/31/2018; 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6-FRENCH SHEATH; J-WIRE .035X150CM
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR