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

Model Number 466P306X

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2009

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease vena cava filter which subsequently malfunctioned and cause injury and damages to the patient, including, but not limited to, tilt, filter embedded to the wall of the ivc, and failed retrieval attempt.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 trapease 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 images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Additionally, the timing and mechanism of the reported filter tilt is unknown.Patient, technique or procedural factors may have contributed to the reported tilt.The brief noted that the filter was embedded in the wall of the ivc.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.Without procedural films for review, the reported retrieval difficulty, unable to retrieve from the vessel wall, could not be confirmed.However, the cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The off label use of this filter likely contributed to the retrieval difficulty experienced by the customer.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 reported by the legal team, the patient underwent placement of the trapease vena cava filter which subsequently malfunctioned and cause injury and damages to the patient, including, but not limited to, tilt, filter embedded to the wall of the ivc, and failed retrieval attempt.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

Additional information was received form a patient profile form (ppf) that there were two failed retrieval attempts.The patient learned that his ivc filter was tilted and unable to be removed approximately one month after filter placement.The second removal attempt was made approximately one month later and was also unable to be removed.A venogram revealed that the filter was tilted with the hook up against the wall.The filter remains implanted.The patient further reports he will require lifelong monitoring of his filter to ensure that it does not fracture, perforate, migrate, or malfunction in some way, creating a life-threatening situation.The patient further reported that he must now live with constant worry and anxiety about the state of his health related to the filter.Additional information received from medical records indicate the preoperative diagnoses at filter placement were left lower extremity acute deep venous thrombosis and pulmonary emboli.The trapease filter was deployed in the ivc below the renal veins.Ah attempt was made to intubate the popliteal vein, but it was full of clot and the physician could not get a wire to easily pass.The physician abandoned this and went down to the posterior tibial vein area.However, these veins were small and once they touched them, they spasmed and the physician could not find them again.It was elected to not go any further.The patient returned to the icu in stable condition.The plan was to surgically expose the posterior tibial veins on the following day.Based on the additional information received, updates were made to the following.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter which subsequently malfunctioned and cause injury and damages to the patient, including, but not limited to, tilt, filter embedded to the wall of the inferior vena cava (ivc), and failed retrieval attempt.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.Additional information was received form a patient profile form (ppf) that there were two failed retrieval attempts.The patient learned that his ivc filter was tilted and unable to be removed approximately one month after filter placement.The second removal attempt was made approximately one month later and was also unable to be removed.A venogram revealed that the filter was tilted with the hook up against the wall.The filter remains implanted.The patient further reports he will require lifelong monitoring of his filter to ensure that it does not fracture, perforate, migrate, or malfunction in some way, creating a life-threatening situation.The patient further reported that he must now live with constant worry and anxiety about the state of his health related to the filter.Additional information received from medical records indicate the preoperative diagnoses at filter placement were left lower extremity acute deep venous thrombosis and pulmonary emboli.The trapease filter was successfully deployed below the renal veins.During that procedure, after filter insertion, the patient was placed in supine position, an attempted cannulation of the left popliteal vein and posterior tibial vein was unsuccessful due to the presence of clots and vein spasms.The patient tolerated the procedure well and was transferred to the icu in stable condition.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 trapease 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.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of nervousness, unease and worry.Without images or procedural films for review, the reported filter tilt and retrieval difficulty could not be confirmed, and the exact cause could not be determined.Additionally, the timing and mechanism of the reported filter tilt is unknown.Patient, technique or procedural factors may have contributed to the reported tilt.The brief noted that the filter was embedded in the wall of the ivc and that two unsuccessful retrieval attempts were made.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.The cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The off-label use of this filter likely contributed to the retrieval difficulty experienced by the customer.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7146856
• MDR Text Key: 95799868
• Report Number: 1016427-2017-00915
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

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 Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/27/2017
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 11/27/2017; 07/12/2018
• Supplement Dates FDA Received: 07/10/2018; 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR