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

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Perforation (2001); Atrial Perforation (2511)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.Approximately eleven years post implantation the patient underwent an updated 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 at least two struts were significantly perforating the inferior vena cava (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.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 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 and perforation 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 per the legal brief, the patient underwent placement of defendants¿ trapease vena cava filter.Approximately eleven years post implantation the patient underwent an updated 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 at least two struts were significantly perforating the inferior vena cava (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.

Manufacturer Narrative

Additional information was received from the patient profile form that the patient there was perforation of the filter struts into the organs.Plaintiff states he has had a habitual cough since after the ivc filter.He is depressed due to not being able to be active as he was before and is constantly worrying about his health due to the ivc placement.At filter placement, pre-operative diagnoses were dvt.The filter was successfully deployed via the jugular approach.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As per the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement was deep vein thrombosis (dvt).The filter was successfully deployed via the jugular approach.Approximately eleven years post implantation an updated ct scan 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 at least two struts were significantly perforating the inferior vena cava (ivc).Per the patient profile form (ppf), the patient reports perforation of the filter struts into the organs, depression and a habitual cough since the ivc filter implantation.The filter remains implanted; thus, unavailable for analysis.The phr could not be conducted because the lot number could not be verified.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.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.Cough and depression 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.

Manufacturer Narrative

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.At filter placement, the pre-operative diagnoses were dvt.The filter was successfully deployed via the jugular approach.Approximately eleven years post implantation, a ct scan revealed the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least two struts were significantly perforating the ivc.Per the patient profile form (ppf), the patient reports perforation of the filter struts into the aorta and organs.The patient also reports a habitual cough, being depressed and constantly worrying.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.It was reported that there was perforation of the ivc and aorta; 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.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.Cough and depression 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.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: 7145570
• MDR Text Key: 95737908
• Report Number: 1016427-2017-00906
• 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,Followup
• Report Date: 07/24/2019

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 Expiration Date: 11/30/2008
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1205187
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 03/09/2018; 07/05/2018; 06/24/2019
• Supplement Dates FDA Received: 04/08/2018; 07/10/2018; 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability