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

Catalog Number 466P306X

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

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 05/04/2014

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.According to the information provided the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, caval thrombosis.The information provided indicated that as a direct and proximate result of this malfunction, the patient, suffered life threatening injuries and damages, and required extensive medical care and treatment.As a further and proximate result, the patient, has suffered and will continue to suffer medical expenses, and pain and suffering and other damages.There is currently no additional information available.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 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 clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.With the limited information provided and no post implant imaging available for review the reported events could not be confirmed or further clarified, nor is it possible to establish a relationship between the reported events and the device.Given the limited information currently 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 defendants¿ trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, caval thrombosis.As a direct and proximate result of this malfunction, the patient, suffered life threatening injuries and damages, and required extensive medical care and treatment.As a further and proximate result, the patient, has suffered and will continue to suffer medical expenses, and pain and suffering and other damages.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter due to having deep vein thrombosis (dvt) and bleeding with hematoma after left hip fracture and repair.As a result, anticoagulation was contraindicated.The patient also has a history of having undergone administration of fresh frozen plasma to reverse the anticoagulation and blood transfusion administration to treat anemia.The ivc filter was placed at the l2-l3 level via right internal jugular vein.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events approximately on or about four years and two months post implantation of the ivc filter when the patient underwent examination of the ivc filter.The patient reports that blood clotting was discovered in the ivc.The patient also reports to suffer from blood clots, clotting, occlusion of the ivc, pain, emotional distress, mental anguish, anxiety, and stress.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 injury and damages to the patient, including, but not limited to, caval thrombosis.The patient is also reported to have experienced blood clots, clotting, occlusion of the ivc, pain, emotional distress, mental anguish, anxiety, and stress.It is reported that the patient became aware of these events approximately four years post implant.The indication for the filter implant was deep vein thrombosis and a contraindication to anticoagulation.The patient presented to the emergency room sometime after having undergone a repair of a left hip fracture.Because of dvt the patient was placed on an anticoagulant.The inr in the emergency room was 4.0, with hematoma, bleeding and anemia.The anticoagulation was reversed with the administration of fresh frozen plasma and the anemia was treated with the administration of a blood transfusion.It was recommended at that time that a filter be placed.The filter was placed via the right internal jugular vein and deployed at the area of l2-l3.There is currently 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 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, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed, nor is it possible to establish a relationship between the reported events and the device.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues and medical history.With the limited information available for review it is not possible to determine a relationship between the device and the reported events.Given the limited information currently 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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7381928
• MDR Text Key: 103842910
• Report Number: 1016427-2018-01311
• 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
• Report Date: 05/31/2018

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 AMPLATZ GUIDE WIRE; UNKNOWN 4 SHEATH WITH INTRODUCER; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR