MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Fracture (1260)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracturing of the filter and two struts remaining embedded in the wall of the inferior vena cava.The filter remains implanted; thus, unavailable for analysis.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 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 predominant concern for embedding with in 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.Endothelialization has been shown to occur in as short a period as 12 days.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 a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracturing of the filter and two struts remaining embedded in the wall of the inferior vena cava.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.

Manufacturer Narrative

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

Event Description

Additional information received per the medical records indicate that the patient endured multiple broken bones following a motor vehicle accident, approximately three to five years prior to the filter implant and became wheelchair bound for ten years.The patient also has a history of chronic back pain and hypertension.The patient developed a right lower extremity deep vein thrombosis and underwent placement of a trapease vena cava filter.Approximately fourteen years later the filter was successfully removed percutaneously; however, during the procedure, the filter fractured, and two struts appear to be incorporated within the inferior vena cava (ivc) wall.There was no evidence of extravasation.A cavogram performed during the procedure revealed that the filter appeared to be at least partially incorporated with in the walls of the ivc and evident narrowing of the ivc at the level of the filter.A computed tomography (ct) venography scan was performed the following day and demonstrated that the tines were still in place and there was irregularity in the ivc wall related to how long the filter had been present.The patient was instructed that the ivc wall remodeling was expected to occur.The scan also noted the appearance of nonocclusive, possibly chronic thrombus in the anterior infrarenal vena cava.Additional information received per the patient profile form (ppf) states that the patient experienced of filter fracture, perforation of filter strut(s) outside the inferior vena cava (ivc), perforation of filter strut(s) into organs, filter embedded, blood clots, clotting and/ or occlusion and filter struts cannot be retrieved.The patient became aware of the reported events approximately fourteen years after the index procedure.The patient maintains that there are fractured struts retained within the ivc wall and pericaval space.The patient also reports chest pain, back pain, ivc injury and severe emotional distress related to the filter.

Manufacturer Narrative

Reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of a motor vehicle accident with multiple broken bones and had been wheelchair bound for the last ten years.The patient also had a history of chronic back pain and hypertension.The indication for the filter placement was reported to be a right lower extremity deep vein thrombosis (dvt).Approximately fourteen years after the filter implantation, the patient underwent successful percutaneous removal of the filter.During the procedure, the filter fractured with two struts embedded within the wall of the inferior vena cava (ivc).These fragments were deemed to be irretrievable.At that time, venogram revealed narrowing of the ivc but no evidence of extravasation.A computerized tomography (ct) scan that performed the next day, revealed the retained fragmented struts in situ.Irregularity of the ivc wall was noted and was attributed to the length of time that the filter had remained in place.The patient was instructed that the ivc wall remodeling was expected to occur.The study further noted the appearance on non-occlusive, possibly chronic thrombus in the anterior infrarenal vena cava.The patient also reported that the filter was associated with perforation of filter strut(s) outside the wall of the ivc and into organs and/or tissues, blood clots, clotting and/or occlusion of the ivc.The patient further reported having experienced chest pain, back pain, mental anguish and severe emotional distress associated with the filter.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, device embedment and perforation (of the ivc, organ and/or tissues) 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.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9517219
• MDR Text Key: 188342589
• Report Number: 1016427-2019-03699
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 02/18/2020; 03/22/2020
• Supplement Dates FDA Received: 03/13/2020; 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Weight: 84