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

Catalog Number 466FXXXX

Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Edema (1820); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.  as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, perforation of the ivc, fractures, embedded to wall of ivc and partial removal 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.No additional information is available.  the product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) 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/fractures and partial removal of the filter 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.The brief also reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.The reported ¿filter embedded in wall of the ivc¿, could not be confirmed and could not be further clarified at this time.The optease vena cava filter is indicated for retrieval up to 23 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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.However, 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 letter for this product file.

Event Description

As reported through the legal department via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, tilt, perforation of the ivc, fractures, embedded to wall of ivc and partial removal of the filter.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for the placement was extensive deep vein thrombosis(dvt) of the left lower extremity, recalcitrant to anti-coagulation therapy.The patient presented to the emergency room with complaints of groin pain that then extended into the leg with increased swelling.Of note, the patient was on contraceptives prior to the event.The patient was started on anticoagulant therapy, but the thrombosis was determined to be progressing.The patient was brought to the catheterization lab for evaluation and possible filter implant.The findings are as follows: left popliteal vein, superficial femoral vein, common femoral vein, and the left iliac vein were all thrombosed.The inferior vena cava was noted to be without thrombus.An optease filter was successfully deployed and a thrombolytic infusion was started using pulse spray and retavase, with follow up angiogram to be performed the following day.According to the information provided, the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to tilt, perforation of the ivc, fractures, embedded to wall of ivc and partial removal 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 received per the patient profile from (ppf) indicates that the patient had the filter removed six years and seven months post implantation via an open abdominal procedure due to recurrent dvt with tilted and fractured ivc filter.Nine days later a computerized tomography(ct) scan revealed a large amount of edema was noted within the ventral and lateral right abdominal wall.There were also areas of increased density suggestive of hemorrhage, according to the ct scan this could be correlated with a recent surgery or trauma.The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress.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 a device history record (dhr) 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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Without images or procedural films for review the reported tilt, embedded, retrieval difficulty,and strut fracture could not be confirmed.Filter fracture and vessel perforation are known adverse events associated with implanting vena cava filters and are listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Clinical factors that may influenced any potential events include underlying patient co-morbidities, pharmacological and lesion characteristics.Post-operative edema and hemorrhage do not represent a device malfunction and may be related to procedural factors associated with the device removal.Anxiety, also, 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 the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.

Manufacturer Narrative

The following additional information received per the patient profile from (ppf) indicates that the patient had the filter removed six years and seven months post implantation via an open abdominal procedure.Nine days after that, the patient underwent an attempt to remove the remaining struts from the body however the attempt was unsuccessful.According to the medical records, during this attempt a large amount of edema was noted within the ventral and lateral right abdominal wall.There were also areas of increased density suggestive of hemorrhage.The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress.According to the medical records, the patient had extensive deep vein thrombosis (dvt) of the left lower extremity and had presented to the hospital with pain and swelling of the left leg prior to the filter implantation.It was noted in the medical records that the left popliteal, the superficial femoral, the common femoral vein and the iliac vein were completely thrombosed.The filter was placed as anticoagulation was not working.The filter was successfully deployed distal to the renal vein during the index procedure and the patient tolerated the index procedure well.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tiperrary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel co., tiperrary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6660343
• MDR Text Key: 78178154
• Report Number: 1016427-2017-00382
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/09/2017
• Date Manufacturer Received: 12/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 46 YR