MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)

Event Date 09/07/2013

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt and blood clots, clotting and/ or occlusion of the ivc.The patient suffered life-threatening injuries and damages, requiring 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

Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt of the inferior vena cava (ivc) filter and perforation of the caval wall.As a direct and proximate result of these malfunctions, the patient suffered life-threatening in 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 following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged events, five years and four months post implantation, after undergoing a computerized tomography (ct) scan.It is noted that the scan showed the filter tilted towards the right lateral inferior vena cava (ivc) wall and that all of the struts along the widest portion of the filter perforated outside of the ivc.The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress.According to the information received in the medical records, the patient has a history of recurrent deep vein thrombosis (dvt) and recurrent pulmonary embolism (pe).The patient has been previously treated with coumadin and was discontinued from coumadin.Prior to the filter placement, the patient was also having persistent vomiting and diarrhea.During the filter implantation procedure, the filter was deployed below the renal veins, via the right common femoral vein.The patient tolerated the procedure well and had no complications.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 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.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.The brief also reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.However, 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 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt and blood clots, clotting and/ or occlusion of the ivc.The patient suffered life-threatening injuries and damages, requiring 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 following additional information received per the implant records indicate that the filter was placed without complications with a post-operative diagnosis of deep vein thrombosis and pulmonary embolus.According to the information received in the patient profile from (ppf), the patient became aware of these events approximately nine months post implantation.The patient reports becoming aware of the ivc thrombosis in an ultrasound.In addition, a ct scan showed the filter to be tilted and fractured.The patient also reports anxiety.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt and blood clots, clotting and/ or occlusion of the ivc.The patient suffered life-threatening injuries and damages, requiring 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 inferior vena cava (ivc) 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 available for review, it is not possible to clarify the location (proximal or distal) of the clots to the placement of the ivc filter.The presence of blood clots do not represent a device malfunction.Placement of a vena cava filter is not a cure for clots nor does it prevent the formation of new clots (thrombosis).Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.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.

• Brand Name: 466P306AU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7612227
• MDR Text Key: 111430235
• Report Number: 1016427-2018-01547
• 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: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15707199
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR