MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

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

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 07/17/2018

Event Type  Injury  

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 caval occlusion, pulmonary embolis (pe) and deep vein thrombosis (dvt).The indication for the filter placement, procedural details and medical history have not been provided and there is 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 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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting, and occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Ivc filters are not indicated for use in the prevention of dvt.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 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, caval occlusion, pulmonary embolis (pe) & deep vein thrombosis (dvt).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

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, d1, d4, d11, g3, g4, g7, h1, h2, h4 and h6.Section h6: patient code '1984' was used for occlusion of the inferior vena cava and filter becoming clogged (device occlusion).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 caval occlusion, pulmonary embolis (pe) and deep vein thrombosis (dvt).The patient reported becoming aware of blood clots, clotting and or occlusion of the inferior vena cava (ivc) approximately eleven years and two months post implant.The patient also reported having to go to the emergency room due to the filter becoming clogged/collapsed, having surgery, and spending five days in the hospital and having physical therapy.Additional information received per the medical records indicate that the patient has a history of subdural hematoma, intracerebral bleed, coagulopathy and pulmonary embolus with dependent thrombosis.The filter was placed via the patient's right femoral vein and deployed below the renal veins.The patient was asked to cough, the filter was unchanged, and the position remained stable.There is currently no additional information available for review.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 trapease vena cava filter is indicated for use in the prevention of recurrent 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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting, and occlusion of the filter or the vasculature related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Ivc filters are not indicated for use in the prevention of dvt.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

Additional information received per the medical records indicate that the patient has a history of subdural hematoma, intracerebral bleed, coagulopathy and pulmonary embolus with dependent thrombosis.The filter was deployed via the patient's right femoral vein.The filter was placed below the renal veins and the patient was asked to cough.The filter was unchanged and remained stable.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 eleven years and two months after the index procedure.The patient reported that she went to the emergency room due to her filter becoming clogged/collapsed.She claims to have had surgery, spent five days in hospital and had physical therapy.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10270368
• MDR Text Key: 198911714
• Report Number: 1016427-2020-04183
• 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: 08/20/2020

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 Expiration Date: 05/31/2009
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0606552
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN INTRODUCER; UNKNOWN PIGTAIL CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR