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); Perforation of Vessels (2135)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

As reported, the patient was implanted the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury, damage, the patient, including, but not limited to filter perforation.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.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.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.

Event Description

As reported by the legal brief, the patient was implanted the trapease filter.The filter subsequently malfunctioned and caused injury, damage, the patient, including, but not limited to: filter perforation.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered & will continue to suffer significant medical expenses, pain and suffering, & other damages.

Event Description

As reported by the legal brief, the patient was implanted the trapease filter.The filter subsequently malfunctioned and caused injury, damage to the patient, including, but not limited to: filter perforation.As a direct and proximate result, 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, pain and suffering and other damages.The following additional information was received per the patient¿s implant records, the filter was implanted prophylactically due to blood clots.The physician recommended to the patient placement of a temporary filter to consider removal when there was no longer a risk for pulmonary embolus.The risks and benefits of a temporary versus a permanent filter were discussed, and the patient requested a permanent filter.A filter sheath was advanced into the vena cava and inferior venacavogram was performed.This revealed no variant anatomy or thrombus in the inferior vena cava (ivc).The trapease filter was deployed infrarenally and repeat venacavogram revealed complete opening of the filter infrarenally.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately five years and nine months post implantation.The patient reports perforation of the filter struts outside the ivc, blood clots, clotting and or occlusion of the ivc.Approximately one year and seven months post implant, the patient suffered a pulmonary embolism (pe) and blood clot.The patient also reports suffering from severe abdominal pain, trouble walking, bending, sleeping, anxiety and a greatly diminished quality of life.The patient further reports stomach swelling, occasional passing of blood, and unexplained infections.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient had implant of a trapease inferior vena cava (ivc) filter.Per the medical records, the filter was implanted prophylactically due to blood clots and pulmonary embolus.The physician recommended to the patient placement of a temporary filter to consider removal when there was no longer a risk for pulmonary embolus.The risks and benefits of a temporary versus a permanent filter were discussed, and the patient requested a permanent filter.A filter sheath was advanced into the vena cava and inferior venacavogram was performed.This revealed no variant anatomy or thrombus in the inferior vena cava (ivc).The trapease filter was deployed infrarenally and repeat venacavogram revealed complete opening of the filter infrarenally.The filter subsequently malfunctioned and caused injury, damage to the patient, including, but not limited to filter perforation.Per the patient profile form (ppf), the patient reports perforation of the filter struts outside the ivc, blood clots, clotting and or occlusion of the ivc.Approximately one year and seven months post implant, the patient suffered a pulmonary embolism (pe) and blood clot.The patient also reports suffering from severe abdominal pain, trouble walking, bending, sleeping, anxiety and a greatly diminished quality of life, stomach swelling, occasional passing of blood, and unexplained infections.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 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; 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.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.Anxiety, walking difficulty and abdominal 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.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.

Event Description

As reported by the legal brief, the patient was implanted the trapease filter.The filter subsequently malfunctioned and caused injury, damage to the patient, including, but not limited to: filter perforation.As a direct and proximate result, 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, pain and suffering and other damages.The following additional information was received per the patient¿s implant records, the filter was implanted prophylactically due to blood clots.The physician recommended to the patient placement of a temporary filter to consider removal when there was no longer a risk for pulmonary embolus.The risks and benefits of a temporary versus a permanent filter were discussed, and the patient requested a permanent filter.A filter sheath was advanced into the vena cava and inferior venacavogram was performed.This revealed no variant anatomy or thrombus in the inferior vena cava (ivc).The trapease filter was deployed infrarenally and repeat venacavogram revealed complete opening of the filter infrarenally.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately five years and nine months post implantation.The patient reports perforation of the filter struts outside the ivc, blood clots, clotting and or occlusion of the ivc.Approximately one year and seven months post implant, the patient suffered a pulmonary embolism (pe) and blood clot.The patient also reports suffering from severe abdominal pain, trouble walking, bending, sleeping, anxiety and a greatly diminished quality of life.The patient further reports stomach swelling, occasional passing of blood, and unexplained infections.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 8647147
• MDR Text Key: 146272912
• Report Number: 1016427-2019-02901
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 0.018 GUIDEWIRE; UNK 0.035 GUIDEWIRE
• Patient Age: 42 YR