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

Model Number 466FXXXX

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2015

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter is tilted and irretrievable after two attempted retrievals.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 the patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.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 optease 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 reported 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 implantation date and attempted retrieval date are unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.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 legal team, the patient underwent placement of the' optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter is tilted and irretrievable after two attempted retrievals.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 the patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.As a further proximate result, the patient has suffered and will continue to suffer significant medical i expenses; and pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the medical records indicate that, the filter was placed via the left femoral vein and deployed without any complications.The patient had been referred from trauma service to have an ivc filter placed.According to the information received in the patient profile from (ppf), the patient reports that the filter had tilted, the device is unable to be retrieved, and the filter is in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.The patient became aware of the alleged failure approximately eight years and five months post implant.Approximately on or about one year and one-month post implantation, the patient underwent an unsuccessful percutaneous retrieval attempt and again for a second unsuccessful attempt five days later.The patient is also reported to experience mental anguish for fear of possible device failure in the future.It was reported that a patient underwent placement of a optease vena cava filter.The information provided indicated that the filter malfunctioned and caused injury and damages to the patient, including, but not limited to, filter is tilted and irretrievable after two attempted retrievals.The following additional information received per the medical records indicate that, the filter was placed via the left femoral vein and deployed without any complications.The patient had been referred from trauma service to have an ivc filter placed.According to the information received in the patient profile from (ppf), the patient reports that the filter had tilted, the device is unable to be retrieved, and the filter is in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.The patient became aware of the alleged failure approximately eight years and five months post implant.Approximately on or about one year and one-month post implantation, the patient underwent an unsuccessful percutaneous retrieval attempt and again for a second unsuccessful attempt five days later, procedural details have not been provided.The patient is also reported to experience mental anguish for fear of possible device failure in the future.There is currently no additional information available for review.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 optease 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 tortuosity.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 33152 ; EI 33152
• MDR Report Key: 7146989
• MDR Text Key: 95790651
• Report Number: 1016427-2017-00916
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/30/2017
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6- FRENCH SHEATH
• Patient Age: 36 YR