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Model Number 466F220A |
Device Problems
Fracture (1260); Difficult to Remove (1528)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 10/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damage to the patient.Approximately eleven years post implant a computerized tomography scan (ct) of the abdomen and pelvis was performed and indicated the optease filter was present, no injury was noted.Approximately two weeks after the ct scan the patient underwent a complex percutaneous retrieval via the right common femoral and right internal jugular.During the procedure it was noted that the struts were projected outside the inferior vena cava (ivc).A loop wire technique was used to snare the filter, resulting in fracturing the filter and only being able to remove part of the filter.The doctor attempted, unsuccessfully, to remove the remaining parts via the right internal jugular.Two stents were inserted.The stents were crushing the filter fragments against the walls of the ivc.Besides the fragments contained by the stents, there was a single strut embedded in the cava wall which remained after multiple attempts to retrieve it.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 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.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 ifu also states that filter fracture with perforation 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.As indicated, the filter fracture most likely occurred during the complex retrieval attempt.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.Please note that this is the initial report for this product.
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Event Description
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As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient.As a direct and proximate result of these malfunctions, the patient suffered bodily injury and resulting in pain and suffering, disability, mental anguish, loss of capacity for enjoyment of life, expense of hospitalization, medical and nursing care and treatment, and will require ongoing medical care and monitoring for the rest of her life.The patient¿s injuries are permanent and continuing and she will suffer such losses in the future.Approximately eleven years after the index procedure the patient underwent a computerized tomography scan (ct) of her abdomen and pelvis that indicated the optease filter was present, no injury was noted approximately two weeks after the ct scan the patient underwent a complex percutaneous retrieval via the right common femoral and right internal jugular.During the procedure it was noted that the struts were projected outside the inferior vena cava (ivc).A loop wire technique was used to snare the filter, resulting in fracturing the filter and only being able to remove part of the filter.The doctor attempted, unsuccessfully, to remove the remaining parts via the right internal jugular.Two stents were inserted.The stents were crushing the filter fragments against the walls of the ivc.Besides the fragments contained by the stents, there was a single strut embedded in the cava wall which remained after multiple attempts to retrieve it.
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Event Description
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According to the medical records received for review, the patient was reported to have a history of factor v leiden deficiency, deep vein thrombosis (dvt) (s/p pregnancy), c-section, migraines, iliac vein stents, breast reduction, osteoarthritis right shoulder, cervicalgia and hypertension.Four days prior to the index procedure, a venous duplex ultrasound of the lower extremities indicated for pain and swelling was positive for extensive dvt on the left.The right side appeared normal.The patient was started on low molecular weight heparin and developed compartment syndrome.The following day, the patient developed large femoral to popliteal dvt and sensory loss associated with phlegmasia cerulea, and the patient underwent compartment fasciotomy.The day of the index procedure, a computed tomography (ct) scan of the abdomen was performed to evaluate the iliac vein.Results of the scan noted thrombus within the left common iliac vein, with extension superiorly into the ivc and inferiorly into both the left superficial femoral and left profunda femoral vein.Apparent compression of the left common iliac vein between the right common iliac artery and adjacent vertebrae, which likely played a role in thrombus formation.The filter was indicated for may-thurner syndrome with iliofemoral thrombosis of the left iliofemoral venous system.The filter was placed via the right common femoral vein and was deployed approximately 1cm below the left renal vein.The patient was then placed prone, and access was obtained via the left saphenous vein.Diagnostic venography showed a patent right iliac venous system and ivc, the left superficial femoral vein was patent, but did have small amounts of clots throughout its course and was patent all the way to the level of the common femoral vein, which was widely patent.The external iliac vein had significant thrombosis at its most proximal aspect and the common iliac vein was entirely thrombosed.Angiojet thrombolysis was performed and there was flow throughout the iliac system, however a significant amount of clot remained.A 10cm infusion catheter was placed from the common femoral to the common iliac vein and a tpa infusion was initiated along with a heparin drip.The following day, venography was performed and demonstrated nonocclusive thrombus along the length of the popliteal and superficial femoral vein with clearing of thrombus at the level of the common femoral vein.No flow was noted into the iliac system.A hand injection was performed and noted a tight stricture just distal to the takeoff of the junction of the left common iliac vein with the inferior vena cava, presumably the area shown on cat scan to be compressed by the right common iliac artery.No thrombus was observed in the iliac system.After much analyzing a 10mm balloon catheter was advanced and angioplasty was performed along the length of the iliac vein.That was followed by a 12mm x 4cm balloon, significant residual stenosis was still observed, so a 14 x 40mm smart stent (sticker illegible) was implanted at the common iliac vein junction with the ivc and post dilated with a 12mm x 4cm balloon.Imaging showed free flow of contrast through the dilated stricture.Repeat venogram of the thigh showed persistent thrombus.Heparin and tpa were re-initiated.The next day a repeat venogram showed both the external common iliac veins on the left side were widely patient with excellent flow and no evidence of thrombus within the ivc filter.The sheath was removed.Four days post implant, left leg fasciotomy closure was performed.About seven years and ten months post implant, the patient underwent right occipital nerve neurectomy for migraines and three months later underwent a right zygomaticotemporal neurectomy for neuritis (migraine nerve decompression).Approximately ten years and ten months after the filter was implanted, the patient presented to the er with left calf swelling and pain.Ultrasound of the leg was positive for dvt, and the patient was restarted on anticoagulants and discharged the following day.About eleven years and five months post implant, a ct scan of the abdomen was performed for activated protein c resistance.Results of the scan noted no acute findings, an ivc filter and cia stents, bilateral ovarian cysts, nabothian cysts and uterine fibroids.Nine days later, the patient presented to the walk-in clinic for back pain after playing volleyball.Evaluation determined lumbosacral muscle spasm.About eleven years and six months after implantation, retrieval of the ivc filter was attempted due to perforation of filter struts outside the ivc.Access was made via the right common femoral vein and a venacavogram was performed demonstrating no evidence of thrombus within the ivc filter or vena cava.The struts of the filter project beyond the wall of the ivc.Attempts to grasp the hook with a goose neck snare were unsuccessful as the snare could not interact with the hook, suggesting it was embedded within the wall of the ivc.The sheath was upsized to a 16french and using 2 glidewires, looped around the struts of the filter, attempts were made to align the filter for removal and almost 90% of the filter was collapsed in the sheath, but the patient was experiencing significant abdominal pain.The patient was placed under deeper sedation and additional attempts to remove the filter were made; filter pieces broke off in the process.Three or four large pieces were removed but the complete filter would not collapse within the sheath.Access was then made via the right internal jugular vein with a 16f sheath.Attempts to grasp the remaining portions of the filter from the jugular approach however the filter was unstable and portions of it were embedded in the ivc wall.The decision was made to leave the remaining pieces of the filter and place two stents in the ivc to jail the fragments.An 18mm x 60mm wallstent was positioned across the filter fragments and deployed crushing the fragments against the ivc.Angioplasty of the ivc was performed with an 18mm balloon at 12 atm.A follow up venacavogram demonstrated excellent flow through the ivc and iliac vessels and no evidence of extravasation.The stent is below the level of the renal vein, the patient will remain on anticoagulation.Fifteen days post retrieval, the patient presented to the er with complaints of left ankle and foot pain.An examination of the foot found no acute fracture or malalignment of the foot.Twelve years and eight months after the filter was implanted the patient developed right shoulder pain.Calcific tendinitis of the rotator cuff and a 6mm mineralized body adjacent to the proximal humeral diaphysis was noted on x-ray.The patient was treated with physical therapy.Two months later a magnetic resonance imaging (mri) showed articular surface tear at the mid supraspinatus footprint and calcific tendinitis.The patient underwent rotator cuff repair twenty three days later.About four months later the patient underwent another rotator cuff repair of the right shoulder.Five months post repair, an mri of the left shoulder indicated for pain showed moderate bursitis.Fourteen years and ten months post filter implantation, the patient presented to the er with complaints of back pain.An mri was performed showing disc herniation at l4-l5, producing moderate left sided foraminal stenosis and mild spondylosis with degenerative disc disease at l5-s1.
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Manufacturer Narrative
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As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused fracture, perforation and retrieval difficulty.Additional information provided indicated that the patient was reported to have a history of factor v leiden deficiency, deep vein thrombosis (dvt) (s/p pregnancy), c-section, migraines, iliac vein stents, breast reduction, osteoarthritis right shoulder, cervicalgia and hypertension.Four days prior to the index procedure, a venous duplex ultrasound of the lower extremities indicated for pain and swelling was positive for extensive dvt on the left.The right side appeared normal.The patient was started on low molecular weight heparin and developed compartment syndrome.The following day, the patient developed large femoral to popliteal dvt, and sensory loss associated with phlegmasia cerulea, and the patient underwent compartment fasciotomy.The day of the index procedure, a computed tomography (ct) scan of the abdomen was performed to evaluate the iliac vein.Results of the scan noted thrombus within the left common iliac vein, with extension superiorly into the ivc and inferiorly into both the left superficial femoral and left profunda femoral vein.Apparent compression of the left common iliac vein between the right common iliac artery and adjacent vertebrae, which likely played a role in thrombus formation.The filter was indicated for may-thurner syndrome with iliofemoral thrombosis of the left iliofemoral venous system.The filter was placed via the right common femoral vein and was deployed approximately 1cm below the left renal vein.The patient was then placed prone, and access was obtained via the left saphenous vein.Diagnostic venography showed a patent right iliac venous system and ivc, the left superficial femoral vein was patent, but did have small amounts of clots throughout its course and was patent all the way to the level of the common femoral vein, which was widely patent.The external iliac vein had significant thrombosis at its most proximal aspect and the common iliac vein was entirely thrombosed.Angiojet thrombolysis was performed and there was flow throughout the iliac system, however a significant amount of clot remained.A 10cm infusion catheter was placed from the common femoral to the common iliac vein and a tpa infusion was initiated along with a heparin drip.The following day, venography was performed and demonstrated nonocclusive thrombus along the length of the popliteal and superficial femoral vein with clearing of thrombus at the level of the common femoral vein.No flow was noted into the iliac system.A hand injection was performed and noted a tight stricture just distal to the takeoff of the junction of the left common iliac vein with the inferior vena cava, presumably the area shown on cat scan to be compressed by the right common iliac artery.No thrombus was observed in the iliac system.After much analyzing a 10mm balloon catheter was advanced and angioplasty was performed along the length of the iliac vein.That was followed by a 12mm x 4cm balloon, significant residual stenosis was still observed, so a 14 x 40mm smart stent was implanted at the common iliac vein junction with the ivc and post dilated with a 12mm x 4cm balloon.Imaging showed free flow of contrast through the dilated stricture.Repeat venogram of the thigh showed persistent thrombus.Heparin and tpa were re-initiated.The next day a repeat venogram showed both the external common iliac veins on the left side were widely patient with excellent flow and no evidence of thrombus within the ivc filter.The sheath was removed.Four days post implant left leg fasciotomy closure was performed.Approximately ten years and ten months post implant, the patient presented to the er with left calf swelling and pain.Ultrasound of the leg was positive for dvt, and the patient was restarted on anticoagulants and discharged the following day.Approximately eleven years post implant a computerized tomography scan (ct) of the abdomen and pelvis was performed and indicated the optease filter was present, no injury was noted.Approximately two weeks after the ct scan the patient underwent a complex percutaneous retrieval via the right common femoral and right internal jugular, due to perforation of filter struts outside the ivc.A venacavogram was performed demonstrating no evidence of thrombus within the ivc filter or vena cava.The struts of the filter project beyond the wall of the ivc.Attempts to grasp the hook with a goose neck snare were unsuccessful as the snare could not interact with the hook, suggesting it was embedded within the wall of the ivc.The sheath was upsized to a 16french and using 2 glidewires, looped around the struts of the filter, attempts were made to align the filter for removal and almost 90% of the filter was collapsed in the sheath, but the patient was experiencing significant abdominal pain.The patient was placed under deeper sedation and additional attempts to remove the filter were made; filter pieces broke off in the process.Three or four large pieces were removed but the complete filter would not collapse within the sheath.Access was then made via the right internal jugular vein with a 16f sheath.Attempts to grasp the remaining portions of the filter from the jugular approach however the filter was unstable and portions of it were embedded in the ivc wall.The decision was made to leave the remaining pieces of the filter and place two stents in the ivc to jail the fragments.An 18mm x 60mm wallstent was positioned across the filter fragments and deployed crushing the fragments against the ivc.Angioplasty of the ivc was performed with an 18mm balloon at 12 atm.A follow up venacavogram demonstrated excellent flow through the ivc and iliac vessels and no evidence of extravasation.The stent is below the level of the renal vein, the patient will remain on anticoagulation.About eleven years and five months post implant, a ct scan of the abdomen was performed for activated protein c resistance.Results of the scan noted no acute findings, an ivc filter and cia stents.The product was not returned for analysis and the sterile lot number is illegible; 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.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.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 ifu also states that filter fracture with perforation 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.As indicated, the filter fracture most likely occurred during the complex retrieval attempt.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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