MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE VENA CAVA FILTER

Model Number N/A

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Perforation (2001); Thrombosis (2100)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease/trapease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.As reported in a legal brief, the patient underwent placement of a trapease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, perforation of the ivc, fracture, and filter thrombus.As a direct and proximal result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.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.Blood clots and thrombosis within the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films for review, the reported filter fracture could not be confirmed and the exact cause could not be determined.The instructions for use (ifu) notes filter fracture and vessel injury as 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.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 in the legal brief (b)(6), the patient underwent placement of a trapease vena cava filter which reportedly subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, perforation of the ivc, fracture, and filter thrombus.As a direct and proximal result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.It was reported that a patient underwent placement of a trapease vena cava filter.The indication for the implant was a history of deep vein thrombosis (dvt) in the left common femoral vein in a patient that needed abdominal surgery.The device was implanted via the right side, post implant imaging revealed the filter to be positioned appropriately within the inferior vena cava.There were no reported complications and the abdominal surgery was scheduled for later in the day.It was initially reported that the filter malfunctioned and caused injury and damages to the patient, including but not limited to, perforation of the ivc, fracture, and filter thrombus.As a direct and proximal result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.Additional information contained in the patient profile form (ppf) indicated that the patient is reported to have experienced clotting, occlusion of the ivc, and the device unable to be retrieved.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.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.The trapease 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.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.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.Anatomical 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.Without the procedural films or post implant imaging available for review the reported events could not be confirmed.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.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

Additional information is pending and will be submitted within 30 days of this report.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of deep vein thrombosis in the left common femoral vein.The indication for filter placement was reported to be the potential for further thrombus formation and thromboembolism in a patient scheduled for a planned reversal of gastric bypass surgery later that month.The filter was implanted via the right femoral vein and appropriately positioned in the distal inferior vena cava (ivc) without complication.Approximately twelve years and a half years after the implantation, the patient became aware that the filter was occluded.More than thirteen years after the implantation, the patient underwent a computerized tomography (ct) scan that revealed perforation of the filter strut(s) outside the ivc and into organs and a possible fracture strut.The fractured strut was reported to be located in the anterior and inferior l3 vertebral body.The device and fractured strut segment remain in situ.The patient also reported that the filter was associated with clotting and thrombus in the device.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 trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 fracture, embedment and ivc perforation events could not be confirmed and the exact cause could not be determined.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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 predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information 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.Should additional information become available, the file will be updated accordingly.

• Brand Name: TRAPEASE VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6511512
• MDR Text Key: 73375683
• Report Number: 1016427-2017-00274
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/27/2017
• Date Manufacturer Received: 01/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR