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Catalog Number 466FXXXX |
Device Problem
Unintended Movement (3026)
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Patient Problems
Myocardial Infarction (1969); Perforation of Vessels (2135); Asystole (4442)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, specific evidence that the filter is tilted and perforates the inferior vena cava (ivc) wall into the prevertebral space and the filter struts perforate the ivc wall with one strut perforating 4-5mm into the right lateral wall of the distal abdominal aorta.The device was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿filter-tilt, inferior vena cava perforation and aortic perforation¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, possible long-term complications associated with filter implantation include, but are not limited to, filter perforation of the vena cava wall.Additionally, the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Without images available for review the reported tilt or perforation could not be confirmed or further clarified.The timing and mechanism of the tilt has not been reported at this time.It is unknown if the tilt contributed to the reported perforation.As no lot number, catalogue code or other product information was supplied a phr could not be completed.The limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Should additional information become available, the file will be updated accordingly.
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Event Description
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As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to specific evidence that the filter is tilted and perforates the inferior vena cava (ivc) wall into the prevertebral space and the filter struts perforate the ivc wall with one strut perforating 4-5mm into the right lateral wall of the distal abdominal aorta.As a direct and proximate result of these malfunctions, the patient has 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.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: as reported a patient underwent placement of an optease vena cava filter.The indication for the filter implant has not been provided.The information provided indicated that the filter subsequently malfunctioned and caused filter tilt and perforates the inferior vena cava (ivc) wall into the prevertebral space with one strut perforating 4-5mm into the right lateral wall of the distal abdominal aorta.The patient reported becoming aware of filter tilt and perforation of filter strut(s) into organ(s) approximately ten years and ten months post implant.The patient also reported blood clots that lead to a heart attack, their heart stopped beating several times and a defibrillator was implanted approximately twelve years and six months post implant.According to the medical records approximately ten years and ten months post implant an abdominal/pelvic computed tomography (ct) scan was done to evaluate the filter.The results noted that the optease filter is at the level of the left renal vein.The apex of the filter lies approximately 2 mm above the left renal vein and 4.2 cm below the level of the right renal vein.The apex of the filter is tilted anteriorly approximately 27 degrees but does not perforate the wall of the ivc.The inferior portion of the filter is tilted posteriorly and perforates 1- 2 mm through the posterior wall of the ivc into the prevertebral space.The struts of the filter extend approximately 4-5 mm beyond the ivc lumen and penetrates into the right lateral wall of the distal abdominal aorta just proximal to the aortic bifurcation.The procedural details and patient medical history have not been provided.The product remains implant and unavailable for analysis, 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 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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.Without images available for review the reported events could not be confirmed or further clarified.Blood clots that travel to the heart and cause a myocardial infarction (mi) do not represent a device malfunction, nor does asystole.An mi is caused by a blockage from plaque or thrombus to a coronary artery.Given the inherent circulatory pathway it is not feasible for an ivc filter to cause an mi.With the limited information available these events could not be further clarified.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.
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Event Description
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Additional information received per the medical records indicate that approximately ten years and ten months after the index procedure an abdominal/pelvic computed tomography (ct) scan was done to evaluate the filter.The images revealed the optease filter at the level of the left renal vein within the inferior vena cava (ivc).The apex of the filter lies approximately 2 mm above the left renal vein and 4.2 cm below the level of the right renal vein.The apex of the filter is tilted anteriorly approximately 27 degrees and contacts the anterior was of the ivc, but does not perforate the wall of the ivc.The inferior portion of the filter is tilted posteriorly and perforates 1 - 2 mm through the posterior wall of the ivc into the prevertebral space.The struts of the filter extend approximately 4-5 mm beyond the ivc lumen and penetrates into the right lateral wall of the distal abdominal aorta just proximal to the aortic bifurcation.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and perforation of filter strut(s) into organ(s).The patient became aware of the reported events approximately ten years and ten months after the index procedure.The patient reported that they also experienced blood clots that lead to a heart attack.Additionally the patient's heart stopped beating several times and a defibrillator was implanted approximately twelve years and six months after the filter was implanted.The patient presented to an emergency room approximately nine years and seven months after in the index procedure with complaints of shortness of breath and chest pain.The patient was monitored and given combivent x3 and methylprednisolone 125 mg iv and felt better, but had never experienced chest pain with prior exacerbations, so the patient was kept for monitoring.On re-examination, some improvement, but persistent dyspnea requiring hospital admission.The clinical impression was chest pain, chronic obstructive pulmonary disease (copd) exacerbation.The record states that the patient had a history of asthma and subjective diagnosis of copd.The patient stated they were non-compliant with their medications, had never had a blood clot and had never been on blood thinners.Additional history was gastric bypass surgery, obesity, tobacco abuse, diabetes, coronary artery disease, prior stroke, peripheral artery disease.Patient also reported that they have never had a blood clot and never been on blood thinners.
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