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

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Dyspnea (1816); Occlusion (1984); Perforation (2001); Swelling (2091); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and was reported to be on or about (b)(6) 2017.The event date being used is (b)(6) 2017.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.On or about/approximately ten (10) years, eleven (11) months, and four (4) days after placement (including the end date), the patient underwent an updated computerized tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and approximately six (6) struts had significantly perforated the ivc.As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.The inferior 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.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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.On or about/approximately ten (10) years, eleven (11) months, and four (4) days after placement (including the end date), the patient underwent an updated computerized tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and approximately six (6) struts had significantly perforated the ivc.As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.No additional information is available.

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 recurrent deep vein thrombosis (dvt).During the placement of the filter via the right internal jugular vein, the filter was deployed in the infrarenal ivc.An ivc-gram demonstrated normal venous anatomy, no thrombus within the ivc, and the filter to have been deployed in the infrarenal ivc.There were no immediate complications, and the patient tolerated the procedure well.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events approximately on or about eleven years post implantation of ivc filter.The patient reports perforation of filter strut(s) outside the ivc, filter to be tilted, filter to be embedded other than in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and the device to be unable to be retrieved.However, no known attempts to remove the filter have been made.The patient also states to have difficulty breathing, chest pain, heart racing, anxiety, sitting up to sleep, trouble sleeping for fear that they will not wake up because of the heart issues related to the ivc filter.The patient reports that their legs are always swollen, having poor circulation, and having had several surgeries due to blood clots.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the inferior vena cava (ivc) filter due to having recurrent deep vein thrombosis (dvt).During the placement of the filter via the right internal jugular vein, the filter was deployed in the infrarenal ivc.An ivc-gram demonstrated normal venous anatomy, no thrombus within the ivc, and the filter to have been deployed in the infrarenal ivc.There were no immediate complications, and the patient tolerated the procedure well.Approximately 11 years after placement, the patient had a ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and approximately six (6) struts had significantly perforated the ivc.Per the patient profile from (ppf), the patient reports perforation of filter strut(s) outside the ivc, filter to be tilted, filter to be embedded other than in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and the device to be unable to be retrieved.However, no known attempts to remove the filter have been made.The patient also reports difficulty breathing, chest pain, heart racing, swollen legs, poor circulation, anxiety, and trouble sleeping.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, difficulty breathing, heart racing, swelling of the legs, poor circulation and pain do 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.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: 7493943
• MDR Text Key: 107575978
• Report Number: 1016427-2018-01444
• 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: 07/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/25/2018
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 7 F FILTER DELIVERY SHEATH; UNKNOWN CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR