MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problems Failure to Align (2522); Material Twisted/Bent (2981)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the filter.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.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.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 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 of the filter.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

The implant date was confirmed to be accurate.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 of the filter.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 medical records: the filter was deployed in the distal inferior vena cava (ivc) just below the level of the renal veins in excellent position.Patient tolerated the procedure well and there were no complications.The filter was implanted due to deep vein thrombosis (dvt) in right leg.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 11 years 8 months post implantation.The patient reports filter embedded in wall of the ivc, deformity of side of filter.The patient also reports suffering from no longer being able to walk long distances like they used to, shortness of breath, tiring quickly, and anxiety.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

The implant date was confirmed to be accurate.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 of the filter.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 medical records: the filter was deployed in the distal inferior vena cava (ivc) just below the level of the renal veins in excellent position.Patient tolerated the procedure well and there were no complications.The filter was implanted due to deep vein thrombosis (dvt) in right leg.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 11 years 8 months post implantation.The patient reports filter embedded in wall of the ivc, deformity of side of filter.The patient also reports suffering from no longer being able to walk long distances like they used to, shortness of breath, tiring quickly, and anxiety.

Manufacturer Narrative

As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.The filter was implanted due to deep vein thrombosis (dvt) in right leg.Per the medical records, the filter was deployed in the distal inferior vena cava (ivc) just below the level of the renal veins in excellent position.Patient tolerated the procedure well and there were no complications.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the filter.Per the patient profile form (ppf), the patient reports filter embedded in wall of the ivc, deformity of side of filter.The patient also reports suffering from no longer being able to walk long distances like they used to, shortness of breath, tiring quickly, and anxiety.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.Kink/bent shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.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.Anxiety, shortness of breath and decreased stamina 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: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7963264
• MDR Text Key: 123669776
• Report Number: 1016427-2018-01933
• Device Sequence Number: 1
• Product Code: DTK
• 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: 05/30/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 88 YR