MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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 09/01/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep venous thrombosis (dvt) and coronary embolus.The device was implanted into the patient¿s groin region.The device in the patient was positively identified by the patient¿s medical records.On or about three years and four months later, the patient received a scan on the abdomen and pelvis.The scan showed that the patient¿s inferior vena cava (ivc) filter was present with extensive thrombus beginning at the top of the ivc filter extending inferiorly into the iliac veins.Additionally, both visualized proximal superficial femoral veins had mild inflammatory process consistent with extensive dvts.On or about ten years and eleven months post implantation, the patient received another scan on his ivc filter, which showed that the filter was present in the infrarenal ivc.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.The product was not returned for analysis.Additionally, as the sterile lot number was not available, the device history record (dhr) review could not be performed.The traptease retrievable 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Blood clots and thrombus does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, 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.

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 venous thrombosis (dvt) and coronary embolus.The device was implanted into the patient¿s groin region.The device in the patient was positively identified by the patient¿s medical records.On or about three years and four months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient¿s inferior vena cava (ivc) filter was present with extensive thrombus beginning at the top of the ivc filter extending inferiorly into the iliac veins.Additionally, both visualized proximal superficial femoral veins had mild inflammatory process consistent with extensive dvts.On or about ten years and eleven months post implantation, the patient received another scan on his ivc filter, which showed that the filter was present in the infrarenal ivc.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

According to the patient profile form (ppf) the device in the patient was positively identified by the patient¿s medical records.On or about three years and four months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient¿s ivc filter was present with extensive thrombus beginning at the top of the ivc filter extending inferiorly into the iliac veins.Additionally, both visualized proximal superficial femoral veins had mild inflammatory process consistent with extensive dvts.On or about ten years and eleven months post implantation, the patient received another scan on his ivc filter, which showed that the filter was present in the infrarenal ivc per the patient profile form (ppf), the patient is suffering from blood clots, clotting and/or occlusion of the ivc, bilateral dvt, pe with infarction.The filter remains implanted; thus, unavailable for analysis.Complaint conclusion: as reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for the treatment of deep venous thrombosis (dvt) and possible pulmonary embolus.This patient had venous insufficiency, peripheral vascular disease and hypercoagulable state.The device was successfully implanted below the renal veins without difficulty, and was restarted on oral anticoagulation, coumadin prior to discharge.During this admission, the patient also underwent mechanical thrombectomy of the lower extremities with adjunct use of thrombolytics.The device was positively identified by the patient¿s medical records.Approximately three years and four months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient¿s ivc filter was present with extensive thrombus beginning at the top of the ivc filter extending inferiorly into the iliac veins.Additionally, both proximal superficial femoral veins had mild inflammatory process consistent with extensive dvts.Approximately ten years and eleven months post implantation, the patient received another scan on his ivc filter, which showed that the filter was present in the infrarenal ivc.Per the patient profile form (ppf), the patient is suffering from blood clots, clotting and/or occlusion of the ivc, bilateral dvt, pe with infarction.The filter remains implanted; thus, unavailable for analysis.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 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, pe, and occlusive 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.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6886045
• MDR Text Key: 87200558
• Report Number: 1016427-2017-00602
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6-FRENCH SYSTEM
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR