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| Model Number 466FXXXX |
| Device Problems
Fracture (1260); Difficult to Remove (1528); Migration (4003)
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| Patient Problems
Pulmonary Embolism (1498); Coagulation Disorder (1779); Death (1802); Edema (1820); Occlusion (1984); Pain (1994); Thrombosis (2100); Cardiogenic Shock (2262); Injury (2348)
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| Event Date 01/12/2019 |
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Event Type
Death
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Manufacturer Narrative
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The catalog number is unknown; if received it will be provided.Complaint conclusion: as reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: ivc breakage, ivc migration, collapse of the ivc around the filter, ivc filter being thrombosed, chronic dvt and subsequent clots leading to chronic edema and pulmonary embolism.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.Additionally, as a direct and proximal result of these listed malfunctions, the patient wrongfully passed away from cardiogenic shock, massive pulmonary embolus and ivc thrombosis.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.The instructions for use (ifu) states 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.Injury to the ivc is a known potential adverse event associated to the use of ivc filters, and in this case may be related to the event of migration.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedural pulmonary embolism, with resulting cardiogenic shock, leading to death is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.Edema does not represent a device malfunction and may be related to underlying patient related issues, specifically the clotting disorders.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.
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Event Description
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As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: ivc breakage, ivc migration, collapse of the ivc around the filter, ivc filter being thrombosed, chronic dvt and subsequent clots leading to chronic edema and pulmonary embolism.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.Additionally, as a direct and proximal result of these listed malfunctions, the patient wrongfully passed away from cardiogenic shock, massive pulmonary embolus and ivc thrombosis.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
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Manufacturer Narrative
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It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused inferior vena cava (ivc) breakage, ivc migration, collapse of the ivc around the filter, ivc filter being thrombosed, chronic dvt and subsequent clots leading to chronic edema and pulmonary embolism.Additionally, the patient passed away from cardiogenic shock, massive pulmonary embolus and ivc thrombosis.According to the patient profile form the patient¿s next of kin reported becoming aware of blood clots, clotting, and/or occlusion of the ivc approximately seven years and five months post implant.The next of kin also reported that due to the filter clogging, the patient experienced mental anguish, thromboembolism, a leg amputation and the patient¿s death.According to the medical records the patient had a history of bipolar disorder, lupus anticoagulant, pulmonary embolism (pe), deep vein thrombosis (dvt), tobacco abuse, chest pain, sick sinus syndrome with a pacemaker implant.Two days prior to the filter implant the patient was admitted with recurrent chest pain.There were no ekg changes or elevation in troponins; however a stress test revealed apical hypokinesia and a left ventricular ejection fraction of 53%.An ivc filter was recommended given the patient¿s poor compliance with coumadin therapy due to substance abuse (ecstasy, cocaine, etoh and marijuana).The filter was placed due to a history of pulmonary embolism (pe) and non-compliance.The filter was placed via the right common femoral vein and deployed at the level of l3.There were no immediate complications and the patient tolerated the procedure well.Approximately six years and four months post implant the patient underwent medical follow ups to establish care.Interrogation of the pacemaker noted that the right ventricular (rv) lead was non-functioning.The anticoagulation was stopped by a hematologist, the hypercoagulable state workup was negative.The last pacemaker interrogation had shown appropriate atrial lead parameters and episodes of atrial tachycardia.Previous pacemaker (ppm) interrogations had been normal.Approximately seven years and four months post implant the patient underwent a generator exchange, the rv lead did not need to be replaced.After the procedure, the patient developed severe lower abdominal pain, hypotension, and a computed tomography (ct) angiogram with iv contrast was done which revealed a large hematoma in the anterior lower abdomen.The patient then developed sudden tachycardia, tachypnea, hypotension and bilateral lower extremity pain, swelling, and numbness.Two days later, a repeat ct scan was performed and reported partially visualized pacemaker leads, right lower lobe atelectasis, free fluid/vasculature, stable size of the 15 x 12 cm likely organized hematoma in the anterior pelvis.The underlying external iliac arteries and veins were not significantly compressed and an infrarenal ivc filter was noted without evidence of compression on the underlying external iliac arteries or veins.The patient developed phlegmasia cerulea dolans with bilateral leg involvement and suspected ivc thrombosis.The patient was taken to the operating room for thrombectomy and ivc filter removal and placement of a different (non-cordis) ivc filter.Ultrasound guidance was used to access the right internal jugular vein with a ministick kit.Imaging confirmed ivc and iliac venous occlusions, however the ivc above the filter was patent except for some free-floating thrombus on the filter.Angiojet was passed in multiple runs via both sides for a total of 250cc effluent.Both vascular ultrasound (ivus) and angiogram then demonstrated patent right and left iliac veins and ivc, except for residual occlusion of the ivc filter.Based on this finding, and the significant renal dysfunction and leg swelling, it was determined that it would be necessary to remove the filter to give a chance of recovery.A non- cordis filter was placed with the hook above the renal veins partially, to allow deployment above the prior ivc filter.Via the left femoral vein, a balloon was advanced and inflated alongside the filter to help loosen it from the wall.The surgeon was then able to remove the filter intact, but not entirely into the sheath.The sheath was replaced, and it was then noted that the new ivc filter had been partially dislodged and was now sideways.The patient became hypoxic and bradycardic and subsequently went into cardiac arrest with hypercapnic respiratory failure.Tee revealed acute saddle pe and right ventricular failure.Angiography confirmed absence of bleeding from iliac veins or ivc.A large left sided pe was confirmed.The patient was taken to the icu in critical condition.Extracorporeal membrane oxygenation (ecmo) was emergently initiated and the patient was returned to the icu in critical condition on epinephrine and norepinephrine infusions as well as continued mechanical ventilation and ecmo support.The following day, results from a ct of the abdomen and pelvis confirmed the ivc filter had been removed and the temporary ivc filter demonstrated 35 degrees tilting with apex insinuating into the left renal vein, likely perforating the ivc wall and terminating within the retroperitoneum.Status post extracorporeal membrane oxygenation (ecmo) cannulas placement, which were in proper position, stable anterior midline extraperitoneal hematoma measuring 12 x 6.8 x 14.3 cm.Small volume perihepatic ascites, fluid of intermediate density (proteinaceous fluid or blood).A ct of the chest a day later reported extensive bilateral atelectasis secondary to aspiration given presence of fluid layering within the dependent trachea and bronchi.Subsequently the patient underwent numerous surgeries including repeated thrombectomies, bronchoscopies, tracheostomy, ecmo cannula revisions, fasciotomies and a below the knee leg amputation.Despite aggressive and ongoing treatment, the patient continued to deteriorate, and subsequently expired approximately eleven years post implant.The patient¿s death certificate listed the manner of death as natural and the immediate causes of death included multi-system organ failure, sepsis, cardiogenic shock, massive pe and ivc thrombosis.Other significant conditions included lupus anticoagulant, prior pe and the presence of an ivc filter.No autopsy was performed.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 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.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.Recurrent pe is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting and/or occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Review of the information provided suggests patient and or procedural factors may have contributed to the reported events and the patient¿s ultimate death.There is nothing in the information provided 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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As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: inferior vena cava (ivc) breakage, ivc migration, collapse of the ivc around the filter, ivc filter being thrombosed, chronic deep vein thrombosis (dvt) and subsequent clots leading to chronic edema and pulmonary embolism.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.Additionally, as a direct and proximal result of these listed malfunctions, the patient wrongfully passed away from cardiogenic shock, massive pulmonary embolus and ivc thrombosis.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.According to the medical records provided, a day prior to the index procedure, the patient was admitted for chest pain and was submitted to an angiogram, a left ventriculogram and a right femoral angiogram.The patient was reported to have a history of cocaine, drug abuse and abnormal stress test.The following day, the patient underwent an inferior vena cavagram and placement of an inferior vena cava filter indicated for a history of pulmonary embolism (pe) and noncompliance with anticoagulation.The inferior vena cavagram showed normal appearing inferior vena cava with normal caliber.The renal veins were identified.The optease retrievable filter was then deployed below the renal veins at the l3 level.The completion inferior vena cavagram showed the filter centered in the ivc below the renal veins and above the iliac confluence.Approximately five years after the filter was implanted, the patient underwent medical follow ups to establish care.At the time, the patient¿s medical history included blood clots, pulmonary embolisms, irregular heartbeat and filter in leg to catch blood clots.Surgical history included a cardiac pacemaker for sick sinus syndrome two years after the filter was implanted and elbow surgery three years post implant.The interrogation noted a nonfunctional pacemaker.The patient was also reported to have a history of pe, status post ivc filter and a questionable history of lupus anticoagulant.The anticoagulation was stopped by a hematologist.The hypercoagulable state workup was negative.The last pacemaker interrogation had shown appropriate atrial lead parameters and episodes of atrial tachycardia.The electrocardiogram (ekg) was reviewed.Previous pacemaker (ppm) interrogations had been normal.A pacemaker and lead extraction was recommended.Of note: the patient reported being diagnosed with a pulmonary embolism in 2008 and that while admitted, the patient was noted to have bradycardia and underwent placement of the pacemaker and implantation of the ivc filter; however, the patient was implanted with the optease ivc filter in 2011 as confirmed by the operative report.Approximately seven years and four months after the filter was implanted, the patient underwent a generator exchange and the pacemaker lead was found not to need to be replaced.After the procedure, the patient developed severe lower abdominal pain, hypotension, and a computed tomography (ct) angiogram with iv contrast was done which revealed a large hematoma in the anterior lower abdomen.The patient then developed sudden tachycardia, tachypnea, hypotension and bilateral lower extremity pain, swelling, and numbness.Two days later, an abdominal and pelvic computerized tomography (ct) scan was indicated for hypotension, tachycardia in setting of large abdominal hematoma, new bilateral lower extremity pain, concern for compartment syndrome.The ct reported partially visualized pacemaker leads; right lower lobe atelectasis; free fluid/vasculature, stable size of the 15 x 12 cm likely organized hematoma in the anterior pelvis.The underlying external iliac arteries and veins were not significantly compressed.The mild fat stranding along the left common femoral artery access site was unchanged.An infrarenal ivc filter was noted along with degenerative changes in the thoracic spine with prominent schmorl node formation of the superior endplate of l5 without evidence of compression on the underlying external iliac arteries or veins.The patient was then taken to the operating room for thrombectomy and ivc filter removal and placement of a different (non-cordis) ivc filter.Ultrasound guidance was used to access the right inter internal jugular (ij) with a ministick kit.Imaging confirmed ivc and iliac venous occlusions as well as patent ivc above the filter except for some free-floating thrombus on the filter.The wires were exchanged for amplatz wires and angiojet was passed in multiple runs via both sides for total of 250cc effluent.Both the vascular ultrasound (ivus) and angio then demonstrated patent right and left iliac veins and ivc except for residual occlusion of the ivc filter.Based on this finding, and the significant renal dysfunction and leg swelling, it was determined that it would be necessary to remove this filter to give a chance of recovery.A non- cordis filter was placed with the hook above the renal veins partially to allow deployment above the prior ivc filter.Via the left femoral venous access, a balloon was advanced and inflated alongside the filter to help loosen it from the wall.The surgeon was then able to remove the filter but not entirely in the sheath.This was removed intact and the sheath replaced.At this point the new ivc filter had been partially dislodged and was now sideways.But the patient acutely decompensated with hypotension.Angiography confirmed absence of bleeding from iliac veins or ivc.A large pe left sided was confirmed.The patient was taken to the icu in critical condition.The following day, results from a ct of the abdoment and pelvis indicated for nausea and vomiting confirmed the ivc filter had been removed and reported status post removal of optease ivc filter, followed by placement of a temporary ivc filter, which demonstrated 35 degrees tilting with apex insinuating into the left renal vein, likely perforating the ivc wall and terminating within the retroperitoneum.Status post ecmo cannulas placement, which were in proper position.Stable anterior midline extraperitoneal hematoma measuring 12 x 6.8 x 14.3 cm.Small volume perihepatic ascites; fluid of intermediate density (proteinaceous fluid or blood).A ct of the chest indicated a day later reported extensive bilateral atelectasis secondary to aspiration given presence of fluid layering within the dependent trachea and bronchi.The patient underwent numerous surgeries including repeated thrombectomies, bronchoscopies, tracheostomy, ecmo cannula revisions, fasciotomies and below knee leg amputation.Despite aggressive and ongoing treatment, the patient continued to deteriorate, and subsequently expired approximately eleven years post implantation.The patient¿s death certificate listed the manner of death as natural and the immediate causes of death included multi-system organ failure, sepsis, cardiogenic shock, massive pe and ivc thrombosis.Other significant conditions included lupus anticoagulant, prior pe and the presence of an ivc filter.No autopsy was performed.According to the patient profile form (ppf), the decedent¿s family became aware that the filter was associated with blood clots, clotting and/or ivc occlusion approximately eleven years post implantation, and additionally reported that the decedent experienced mental anguish, pain, thromboembolism and a subsequent leg amputation related to the filter, leading to death.
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