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

Model Number 466P306X

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

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Swelling (2091); Thrombosis (2100); Respiratory Failure (2484)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter thrombosis, ivc clotting above the filter, acute pe requiring eight day hospitalization, acute respiratory failure, hypoxemia, and right lower extremity leg swelling.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, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not 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 and occlusion of the ivc filter does not represent a device malfunction.Leg swelling also does not represent a device malfunction.Clinical factors that may have influenced the events described include patient, pharmacological, lesion characteristics or other comorbidities, such as venous insufficiency which is known to lead to possible swelling and pain of the lower extremities.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.The reported acute respiratory failure and hypoxemia may have been a result of the pulmonary embolism.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 team, the patient underwent placement of the trapease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter thrombosis, ivc clotting above the filter, acute pe requiring eight day hospitalization, acute respiratory failure, hypoxemia, and right lower extremity leg swelling.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, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of bilateral deep vein thrombosis (dvt) and pe.During the filter placement procedure via the femoral vein, the filter was deployed in good position below the level of the renal veins above the iliac bifurcation.The patient tolerated the procedure well and had no immediate post-procedure complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, inferior vena cava (ivc) filter thrombosis, ivc clotting above the filter, acute pulmonary embolism (pe) requiring eight day hospitalization, acute respiratory failure, hypoxemia, and right lower extremity leg swelling.Per the patient profile form (ppf), the patient became aware of the events approximately five years and nine months post implantation.The patient reports to have blood clots, clotting, occlusion of the ivc and that the device is unable to be retrieved.There have been no known attempts made to remove the filter.The patient also reports to be suffering from fear, stress and anxiety.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot 15026226 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, pe and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Acute respiratory failure and hypoxemia may be related to the reported pe, these are known potential adverse event associated with the use of the filter devices.Swelling of the legs does not represent a device malfunction and may be related to underlying patient related issues.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.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged events on or about five years and nine months post implantation.The patient reports to have blood clots, occlusion of the ivc and that the device is unable to be retrieved.There have been no known attempts made to remove the filter.The patient also reports to be suffering from fear, stress and anxiety.According to the information received in the medical records, the patient has a history of bilateral deep vein thrombosis (dvt) and pe.During the filter placement procedure via the femoral vein, the filter was deployed in good position below the level of the renal veins above the iliac bifurcation.The patient tolerated the procedure well and had no immediate post-procedure complications.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 33152 ; EI 33152
• MDR Report Key: 7061263
• MDR Text Key: 93031153
• Report Number: 1016427-2017-00839
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2018

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: 08/31/2012
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15026226
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/01/2017
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 03/03/2018; 06/09/2018
• Supplement Dates FDA Received: 06/01/2018; 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 51 YR