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

Catalog Number 466FXXXX

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of optease vena cava filter.Approximately 9 years, 8 months post implantation the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, 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 (dhr) review could not be performed.The inferior 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 filter tilt 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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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.

Event Description

As reported by the legal brief, the patient underwent placement of defendant's' optease vena cava filter.Approximately 9 years, 8 months post implantation the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Additional information was received from medical records received indicate the ivc filter was deployed just distal to the entrance of the right and left renal veins under fluoroscopic control without difficulty.The patient tolerated the procedure well with no complications encountered throughout the case.Additional information received from the patient profile form indicates the filter has tiled and perforated the ivc.The patient is concerned that his filter will migrate, fracture, perforate further through his ivc, tilt and cause blood clots.Based on the additional information, the following sections were updated were updated accordingly.Additional information was is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of a optease vena cava filter.The information provided indicated that a computerized tomography (ct) scan, performed approximately nine years and eight months post implant, revealed that the filter had tilted and at six struts were perforating the inferior vena cava (ivc).Additional information received from the patient profile form indicates the filter has tiled and perforated the ivc.The medical records indicate the ivc filter was deployed just distal to the entrance of the right and left renal veins under fluoroscopic control without difficulty.The patient tolerated the procedure well with no complications encountered throughout the case.There is currently no additional information available.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 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 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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Post implant imaging has not been provided.The timing and mechanism of the tilt and perforation has not been reported at this time and 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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.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 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.

Manufacturer Narrative

The catalog number is unknown; if received, it will be provided.Complaint conclusion: as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for placement was extensive dvt (deep vein thrombosis) with pulmonary emboli (pe).The ivc filter was deployed distal to the entrance of the right and left renal veins under fluoroscopic control without difficulty.The patient tolerated the procedure well with no complications encountered throughout the case.The filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).Approximately 9 years, 8 months post implant, a ct scan which revealed that the filter was significantly tilted and 6-prong perforation grade ii (two); ivc filter broken, posterior limbs bent inwards, one of the wires of the ivc filter abutting the right margin of the aorta, and thrombosis of the femoral veins extending into the iliac veins and ivc.Per the patient profile form (ppf), the patient reports the filter has tilted and perforated the ivc.The patient further reports anxiety.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.The instructions for use (ifu) states filter fracture with perforation 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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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 tortuousness.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.

Event Description

As reported by the legal brief, the patient underwent placement of defendant's' optease vena cava filter.Approximately 9 years, 8 months post implantation the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Medical records received indicate the ivc filter was deployed just distal to the entrance of the right and left renal veins under fluoroscopic control without difficulty.The patient tolerated the procedure well with no complications encountered throughout the case.Additional information received from the patient profile form indicates the filter has tiled and perforated the ivc.The patient is concerned that his filter will migrate, fracture, perforate further through his ivc, tilt and cause blood clots.According to the discovery form, medical conditions outlined are extensive deep venous thrombosis (dvt) with pulmonary emboli (pe).Medical conditions and treatments alleged to be attributable to the implanted ivc filter include 6-prong perforation grade ii (two); ivc filter broken, posterior limbs bent inwards, one of the wires of the ivc filter abutting the right margin of the aorta, and thrombosis of the femoral veins extending into the iliac veins and ivc.The patient further reports physical pain and suffering, emotional pain and suffering, loss of enjoyment of life, physical disfigurement, past and future medical bills, and other related medical treatment costs.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7145491
• MDR Text Key: 95729349
• Report Number: 1016427-2017-00900
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2019

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 46 YR