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

Catalog Number 466P306AU

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to, a chronic occlusion and thrombosis of bilateral iliac and femoral veins, extensive occlusive thrombus of bilateral iliofemoral veins and lack of blood flow in the inferior vena cava (ivc).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 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 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.Thrombosis and occlusion 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 filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to chronic occlusion thrombosis of bilateral iliac and femoral veins, extensive occlusive thrombus of bilateral iliofemoral veins and lack of blood flow in the inferior vena cava (ivc).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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b7, d1, d4, d6, d11, g3, g4, g7, h1, h2, h4 and h6.Section b5: additional information received per the medical records indicate that the patient has a history of pulmonary embolism, deep vein thrombosis with the threat of additional clot burden causing respiratory compromise.The filter was deployed via the patient's right common femoral vein.It was placed in the infrarenal area above the iliac vein confluence.  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).Approximately six years and ten months after the index procedure there was an unsuccessful attempt to remove the filter, device was unable to be retrieved.The form also states that the patient's legs hurt constantly, it is hard for him to walk and he cannot have intercourse with his wife because his testicles have swollen due to the filter being clogged.The patient has also experienced mental anguish, stress and anxiety.As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes pulmonary embolism and deep vein thrombosis (dvt).The filter was deployed in the infrarenal area above the iliac vein confluence.The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to chronic occlusion thrombosis of bilateral iliac and femoral veins, extensive occlusive thrombus of bilateral iliofemoral veins and lack of blood flow in the ivc.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the inferior vena cava (ivc).Approximately six years and ten months after the index procedure there was an unsuccessful attempt to remove the filter, device was unable to be retrieved.The patient further reports anxiety, constant leg pain, difficulty walking and testicular swelling.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 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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Blood clots, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, testicular swelling and leg pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.Section h6: patient code '1984' was used for 'occlusion of device' and 'occlusion of a vessel'.Corrected data section e1: initial reporter name and address.Section g1: reporting contact facility name.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8660657
• MDR Text Key: 146801181
• Report Number: 1016427-2019-02925
• 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: 07/18/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0208659
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 57 YR