MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Death (1802); Emotional Changes (1831); Pain (1994); Injury (2348)

Event Date 11/15/2018

Event Type  Death  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, senior counsel, litigation.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.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting 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 patient is deceased, but there is no information to relate his demise to the device.

Manufacturer Narrative

After further review of additional information received.As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting 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.In addition, the patient is reported to have expired; though there is no information to suggest that this event was related to the device.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 inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The patient is also reported to have expired.However, there is no information provided to suggest that this event was related to the device.Given the limited information 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

Concomitant devices: 5f wire complaint conclusion: it was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter tilted and the patient experienced anxiety as a result of the filter tilt.The indication for the filter implant was left calf vein thrombosis and a subdural hematoma.The filter was placed via the right common femoral vein and deployed between the renal vein confluence and vena cava bifurcation.The patient reportedly tolerated the procedure well.The information provided indicates that the patient is deceased, however the circumstance, cause or date of the death or a relationship to the device has not been provided.There is currently no additional information available for review.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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.The timing and mechanism of the tilt has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event, without imaging available for review.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information available for review an no cause of death listed it is not possible to draw a conclusion or establish a relationship between the device and the event.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 underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting 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 patient is deceased, but there is no information to relate his demise to the device.The following additional information was received per the patient¿s implant records: the patient had a history of left calf vein thrombosis and subdural hematoma.The filter was deployed between the renal vein confluence and vena cava bifurcation.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately eleven years and seven months post implantation.The ivc filter tilted which caused emotional distress, mental anguish, anxiety and stress.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8161027
• MDR Text Key: 130308312
• Report Number: 1016427-2018-02356
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2008
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306X
• Device Lot Number: R1105653
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/19/2019; 03/28/2019
• Supplement Dates FDA Received: 01/21/2019; 04/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 64 YR