|
Model Number 466P306X |
Device Problem
Failure to Align (2522)
|
Patient Problems
Internal Organ Perforation (1987); Perforation of Vessels (2135)
|
Event Date 03/20/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, tilting and perforation of all filter struts outside the wall of the ivc, with multiple struts perforating surrounding tissue/organs.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.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.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.Ivc perforation from filters is relatively common, and directly related to how long the filter has been in place.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 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 in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, tilting and perforation of all filter struts outside the wall of the inferior vena cava (ivc), with multiple struts perforating surrounding tissue/organs.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, pain and suffering, and other damages.
|
|
Event Description
|
As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, tilting and perforation of all filter struts outside the wall of the inferior vena cava (ivc), with multiple struts perforating surrounding tissue/organs.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, pain and suffering, and other damages.Per the implant records, the patient was reported to a history of morbid obesity, hypertension, obstructive sleep apnea, insulin dependent diabetes mellitus, bilateral lower extremity edema and varicosities, and was scheduled to undergo laparoscopic roux-en-y gastric bypass surgery.Placement of the inferior vena cava filter was indicated for prevention of pulmonary emboli (pe).The right groin and right lower abdomen were prepped and draped in the normal sterile fashion.The right femoral arterial pulse was palpated, and the right femoral vein was located and cannulated without complication.Under fluoroscopic guidance, a glidewire was passed through the needle and up into the inferior vena cava.A series of venograms were then performed locating l2, and a cordis nitinol inferior vena cava filter was then inserted under direct visualization and was placed after adequate identification of the renal veins at the level below the renal veins at approximately l2-3 junction and it was deployed.The patient tolerated the procedure well and was taken to the recovery room in stable condition.Approximately fourteen years and eleven months after the filter was implanted, the patient underwent a computed tomography (ct) scan of the abdomen and pelvis indicated for filter evaluation.The ct scan reformatted images were submitted for review approximately two months later.Per ct review findings, the ivc filter is perforating through the ivc with multiple struts extending extraluminal.The superior end of the cordis trapease ivc filter is at the l2-3 interspace.The ivc filter is tilted anteriorly at the superior end and it is also tilted posteriorly at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 5mm.One anterior strut perforates the ivc wall 4mm and contacts the bowel; one medial strut perforates the ivc wall 4mm and contacts the bowel.One medial strut perforates the ivc wall 3mm and resides within the soft tissues.One posterior strut perforates the ivc wall 5mm and contacts the l3-4 disc.Two lateral struts perforate the ivc wall 4mm and 5mm and contact the bowel.The report also noted that the original function of this ivc filter is permanent; therefore, it cannot be removed by a percutaneous approach.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately fifteen years after the filter implantation.The patient reports ivc perforation, perforation of filter strut(s) into organs and tilting of the filter.The patient further asserts to have dealt with constant infections in the area of the filter producing an odor, discomfort, physical sexual discomfort and anxiety post implant.
|
|
Manufacturer Narrative
|
As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of morbid obesity, hypertension, obstructive sleep apnea, insulin dependent diabetes mellitus, bilateral lower extremity edema and varicosities.The indication for the filter placement was reported to be as prevention of pulmonary emboli in the setting of upcoming, scheduled laparoscopic gastric bypass surgery.The filter was implanted via the right femoral vein and placed in an infrarenal position at the level of the l2-l3 junction.The patient is reported to have tolerated the procedure well.Almost fifteen years after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that the filter had perforated through the wall of the inferior vena cava (ivc) with multiple struts extending beyond the ivc by up to 5mm.One anterior strut and two lateral struts were in contact with the bowel, a medial strut was within the soft tissues and a posterior strut was in contact with the l3-l4 disc.The superior aspect of the filter was located at the level of the l2-l3 interspace.The ct scan also noted that the superior aspect of the filter had tilted anteriorly and the inferior aspect had tilted posteriorly.The ct scan report further noted that the implanted filter was intended to be permanent and was therefore irretrievable from a percutaneous approach.The patient further reported having experienced mental anguish, anxiety and constant infections with related odor, discomfort, physical sexual discomfort associated with the filter.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease vena cava filter is indicated for use in the prevention of recurrent 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 images or procedural films for review, the reported filter tilt and ivc and organ perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (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.Due to the nature of the complaint, the reported pain/discomfort and access site infection 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.
|
|
Search Alerts/Recalls
|
|
|