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

Catalog Number 466P306X

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

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 03/24/2006

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date in the report is the complaint awareness date.As reported, the patient had a trapease inferior vena cava (ivc) implanted.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt and embedment of the ivc filter, multiple failed retrieval attempts, and the filter cannot be retrieved.As a direct and proximate result of these malfunctions, the patient has 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.No additional information is available.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 optease 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 reported filter tilt and 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.Additionally, the timing and mechanism of the reported filter tilt is unknown.Patient, technique or procedural factors during the attempted retrieval may have contributed to the reported tilt.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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient had a trapease inferior vena cava (ivc) implanted.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt and embedment of the ivc filter, multiple failed retrieval attempts, and the filter cannot be retrieved.As a direct and proximate result of these malfunctions, the patient has 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.No additional information is available.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates that the patient underwent the unsuccessful attempt to remove the filter seventeen days post implantation.The patient also reports to be suffering from anxiety.According to the information received in the medical records, the patient was morbidly obese.The filter was recommended as the patient was to undergo an open bypass surgery was at risk for pulmonary embolus (pe).During the implantation procedure, the ivc was measured to be 22.92 mm in diameter.The filter was deployed via the jugular vein within the infra-renal segment of the ivc.A post placement inferior venacavagram showed the filter to be in good position.It was reported that a patient had a trapease inferior vena cava (ivc) implanted.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt and embedment of the ivc filter, multiple failed retrieval attempts, and the filter being unable to be retrieved.Only one documented attempt to retrieve the device has been noted on the information provided.The following additional information received per the patient profile form (ppf) indicates that the patient underwent the unsuccessful attempt to remove the filter seventeen days post implantation, the procedural records have not been provided.The patient also reports to be suffering from anxiety.According to the information received in the medical records, the patient was morbidly obese.The filter was recommended as the patient was to undergo an open bypass surgery and was at risk for pulmonary embolus (pe).During the implantation procedure, the ivc was measured to be 22.92 mm in diameter.The filter was deployed via the jugular vein within the infra-renal segment of the ivc.A post placement inferior venacavagram showed the filter to be in good position.There is currently no additional information available.The product was not returned for analysis and the sterile lot number has not been provided; therefore, neither a device analysis nor device history record (dhr) 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 procedural films for review, the reported filter tilt and retrieval difficulty could not be confirmed, and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.With the limited information provided and no post implant imaging available for review it is not possible to establish a relationship between the reported events and the device.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7213619
• MDR Text Key: 98026177
• Report Number: 1016427-2018-01088
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/26/2017
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 03/03/2018
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.018 GUIDEWIRE; UNKNOWN 0.035 J GUIDEWIRE; UNKNOWN 4F SINGLE END HOLE CATHETER; UNKNOWN 5F HEMOSTATC SHEATH; UNKNOWN 5F PIGTAIL CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR