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

Catalog Number 466P306AU

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

Patient Problems Thrombosis (2100); Stenosis (2263)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis and pulmonary embolism.The device was placed at the bottom of l2/l3 body.The device in the patient was positively identified by medical records.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the body.The following additional information received per the patient profile form (ppf) indicates that the patient is suffering from fear.According to the information received in the medical records, ten years and three months post implantation, the patient underwent a computerized tomography (ct) scan which notes that the filter is below the renal vein confluence.The struts are largely extra-luminal and the inferior vena cava (ivc) is suspected to be chronically thrombosed given increased density and calcifications within the central lumen of the ivc.Renal artery atherosclerosis and possible stenosis were present.Per the medical records, the patient has a history of inflammatory bowel disease, colitis, perforated viscus and acute abdomen.Prior to the filter procedure, the patient was being worked up for kidney stones when a routine ct scan showed a clot in the pulmonary artery.The patient¿s pre-operative diagnosis prior to the filter placement was left femoral deep vein thrombosis (dvt) with pulmonary embolism (pe).During the filter placement procedure via the right common femoral vein, the filter was deployed without difficulty at the bottom of the l2/l3 body.The patient was transferred to receive treatment for the kidney stones under the same anesthesia.The stones were broken up and an unsuccessful attempt was made to retrieve them due to their location.An unknown stent was placed during the procedure.Twenty-one days post implantation, the patient presented for a cystoscopy and bilateral stent removal due to hematuria.The patient previously had bilateral renal stones treated and stents had been left in place.The patient is noted to have been on anticoagulation for pe.

Manufacturer Narrative

As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for the treatment of deep vein thrombosis and pulmonary embolism.The device was placed at the bottom of l2/l3 body.Per the medical records, the patient has a history of inflammatory bowel disease, colitis, perforated viscus and acute abdomen.Prior to the filter procedure, the patient was being worked up for kidney stones when a routine ct scan showed a clot in the pulmonary artery.The patient¿s pre-operative diagnosis prior to the filter placement was left femoral deep vein thrombosis (dvt) with pulmonary embolism (pe).During the filter placement procedure via the right common femoral vein, the filter was deployed without difficulty at the bottom of the l2/l3 body.The patient was transferred to receive treatment for the kidney stones under the same anesthesia.The stones were broken up and an unsuccessful attempt was made to retrieve them due to their location.An unknown stent was placed during the procedure.Twenty-one days post implantation, the patient presented for a cystoscopy and bilateral stent removal due to hematuria.The patient previously had bilateral renal stones treated and stents had been left in place.The patient is noted to have been on anticoagulation for pe.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.Per the patient profile form (ppf), the patient is suffering from fear.Per the medical records, ten years and three months post implantation, the patient underwent a computerized tomography (ct) scan which notes that the filter is below the renal vein confluence.The struts are largely extra-luminal and the inferior vena cava (ivc) is suspected to be chronically thrombosed.Renal artery atherosclerosis and possible stenosis were present.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot r0107542 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.Blood clots and thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Renal artery stenosis does 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7578730
• MDR Text Key: 110446170
• Report Number: 9616099-2018-02176
• 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,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0107542
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR