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

Model Number 466P306AU

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Claudication (2550)

Event Date 10/01/2013

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.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, caval thrombosis and post-implant pain.As a direct and proximate result of these malfunctions, 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, 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 thrombosis to the placement of the ivc filter.Thrombosis and post implant pain do not represent a device malfunction.Large thrombus within the vena cava may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.

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, caval thrombosis, post-implant pain.As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.

Manufacturer Narrative

Updated section as lot number was confirmed.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, post-implant pain.According to the information received the patient became aware of the reported events approximately nine years post implant after submitting for a magnetic resonant imaging (mri) scan.Three days later, more evaluation was performed, unspecified, and it was determined that nothing further could be surgically done.The patient reports blood clots, clotting, and/or occlusion of the ivc, venous claudication, and that the device is unable to be retrieved; however, a documented retrieval attempt has not been provided.The patient is also reported to have experienced pain and anxiety, the anatomical location of the pain has not been provided.The indication for the device implant was recurrent deep vein thrombosis (dvt) of the right lower extremity, past pulmonary embolism (pe) and unspecified difficulty with anticoagulation.The filter was placed via the left femoral vein and deployed with the tip at the l2-l3 position.There were no reported problems related to the procedure.There is currently no additional information available.The product was not returned for analysis.The dhr could not be completed.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.Without films of the index procedure or post implant imaging, the reported caval thrombosis and retrieval difficulty could not be confirmed or further clarified at this time.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 not be confirmed.Pain and venous claudication do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not 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 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, caval thrombosis, post-implant pain.As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the filter was implanted between l2 and l3 via the left femoral vein due to dvt on the right lower extremity.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately nine years post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc, venous claudication, and that the device is unable to be retrieved; however, a retrieval attempt has not been made.The patient also reports suffering from pain and anxiety.

Manufacturer Narrative

Implant date was confirmed.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

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

Manufacturer Narrative

Complaint conclusion: 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, post-implant pain.According to the information received the patient became aware of the reported events approximately nine years post implant after submitting for a magnetic resonant imaging (mri) scan.Three days later, more evaluation was performed, unspecified, and it was determined that nothing further could be surgically done.The patient reports blood clots, clotting, and/or occlusion of the ivc, venous claudication, and that the device is unable to be retrieved; however, a documented retrieval attempt has not been provided.The patient is also reported to have experienced pain and anxiety, the anatomical location of the pain has not been provided.The indication for the device implant was recurrent deep vein thrombosis (dvt) of the right lower extremity, past pulmonary embolism (pe) and unspecified difficulty with anticoagulation.The filter was placed via the left femoral vein and deployed with the tip at the l2-l3 position.There were no reported problems related to the procedure.There is currently no additional information available.The product was not returned for analysis and the sterile lot number provided is invalid; 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.Without films of the index procedure or post implant imaging, the reported caval thrombosis and retrieval difficulty could not be confirmed or further clarified at this time.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 not be confirmed.Pain and venous claudication do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not 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.

Manufacturer Narrative

No subsequent information is available at this time.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7207191
• MDR Text Key: 97799588
• Report Number: 1016427-2018-01032
• 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,Followup
• Report Date: 09/07/2018

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 Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1003666
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 03/09/2018; 05/07/2018; 05/07/2018; 05/02/2018
• Supplement Dates FDA Received: 04/08/2018; 04/08/2018; 06/07/2018; 07/16/2018; 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR