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

Catalog Number 466P306X

Device Problem Obstruction of Flow (2423)

Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 07/11/2021

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of pulmonary embolism (pe) and lower extremity deep vein thrombosis (dvt).The patient had recently sustained pelvic and lower extremity fractures requiring immobilization.The indication for the filter placement was reported to be for the patient¿s high risk for recurrent dvt and the presence of additional clots in the lower extremity.The filter was implanted via the right common femoral vein and placed in an infrarenal position.More than eleven years after the filter implantation, the patient became aware that the filter was associated with blood clots, clotting and/or occlusion of the inferior vena cava (ivc), along with filter and caval thrombosis.The patient further reported having experienced abdominal pain and anxiety associated with the filter.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 pe via percutaneous placement in the 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, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to clot in the filter 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a preoperative diagnosis of pulmonary embolism (pe), lower extremity deep venous thrombosis (dvt) and had sustained pelvic and lower extremity fractures requiring immobilization.Due to the high risk of recurrent dvt as well as the presence of additional clots in the lower extremity, a filter was recommended.Both groins were sterilely prepped and draped.The right common femoral vein was accessed, and a guidewire was passed into the inferior vena cava (ivc).The sheath for the trapease filter was then placed under fluoroscopic visualization and a venogram was performed identifying the renal arteries at the level of about l1, and the inferior vena cava free of thrombus or extravasation.The filter was deployed at about the level of l2.A completion venogram revealed the filter in good position.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, occlusion of the ivc and caval thrombosis, becoming aware of these events approximately eleven years and ten months after the filter implantation, and further experienced abdominal pain and anxiety related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12337848
• MDR Text Key: 267109241
• Report Number: 1016427-2021-05298
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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
• Date Manufacturer Received: 07/29/2021
• 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: UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR