MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

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

Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2021

Event Type  Injury  

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, dvt and caval thrombosis.As a direct and proximate result, 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.

Manufacturer Narrative

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 thrombosis (dvt) and caval thrombosis.The indication for the filter implant has not been provided and 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 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, and thrombosis and/or occlusion within the device or the ivc and/or the vasculature does 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).Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.Ivc filters are not indicated for use in the prevent of dvt.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.

Manufacturer Narrative

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 thrombosis (dvt) and caval thrombosis.The patient reported becoming aware of dvt, blood clots, clotting and/or occlusion of the inferior vena cava (ivc), approximately eight years and eleven months post implant.The patient also reported shortness of breath/trouble breathing, fatigue and chest pain related to the filter.According to the medical records the indication for the filter implant was closed head injury with craniotomy, blunt chest trauma, ventilator dependent, and high risk for dvt and pulmonary embolism (pe).The filter was placed via the right femoral vein and deployed inferior to the renal veins.The patient tolerated the procedure well.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 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, and thrombosis and/or occlusion within the device or the ivc and/or the vasculature does 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).Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.Ivc filters are not indicated for use in the prevent of dvt.Breathing difficulties, fatigue and chest pain do not present a device malfunction and may be related to underlying patient specific issues and comorbidities, such as prior chest trauma.There is nothing to suggest that the reported events are 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of closed head injury, craniotomy, blunt chest trauma, ventilator dependent, high risk for deep venous thrombosis (dvt) and pulmonary embolism (pe).The filter was implanted via the patient's right femoral vein.The filter was deployed inferior to the renal veins.The patient tolerated the procedure well.Additional information received per the patient profile form (ppf) states that the patient experienced deep vein thrombosis (dvt), blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events approximately eight years and eleven months after the index procedure.The patient reported that they continue to experience shortness of breath/trouble breathing, fatigue and chest pain related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14620192
• MDR Text Key: 293457678
• Report Number: 9616099-2022-05694
• Device Sequence Number: 1
• Product Code: DTK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• 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
• Treatment: UNKNOWN DILATOR.; UNKNOWN GUIDE WIRE.; UNKNOWN INTRODUCER SHEATH.; UNKNOWN.
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male