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CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number 466FXXXX |
| Device Problems
Obstruction of Flow (2423); Malposition of Device (2616); Unintended Movement (3026)
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| Patient Problems
Coagulation Disorder (1779); Perforation (2001); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
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| Event Date 07/12/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Additional information is pending and will be submitted within 30 days upon receipt.
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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 tilting of the filter, perforation and subsequent blood clots.
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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 tilting of the filter, perforation and subsequent blood clots.The patient reported becoming aware of perforation of filter struts outside the ivc, blood clots, clotting and occlusion of the ivc, approximately sixteen years and seven months post implant.The patient also reported anxiety related to the filter.According to the medical records, the patient had a history of recurrent deep vein thrombosis (dvt).The patient underwent catheter directed thrombolytic therapy with stenting with concomitant placement of the inferior vena cava (ivc) filter.About sixteen years post implant, the patient presented to the hospital with complaints of low back pain for a week and awoke the day of presenting with acute swelling, discoloration (blue) and pain of the right leg.The patient was not on anticoagulation at the time, and a doppler ultrasound revealed dvt within the right common femoral, superficial femoral and popliteal veins.The thrombus appeared to be extending to the posterior tibial veins as well as extending superiorly into the iliac vessels.The patient underwent venogram of the right popliteal vein and placement of a catheter for overnight tissue plasminogen activator (tpa).The indication was phlegmasia cerulea dolens of the right lower extremity, previous dvt, pulmonary embolism (pe) and ivc filter.The venogram showed extensive thrombus extending from the ivc filter all the way down into the right femoral venous system.The following day the patient underwent angiography and aspiration thrombectomy a massive amount of clot was removed from the ivc and the right iliofemoral system up to the filter.Clot could not be removed from the ivc filter.The patient was discharged three days later.Approximately sixteen years and seven months post implant, an abdominal computerized tomography (ct) scan was indicated for filter evaluation.The report noted an ivc filter in place with anterior tilt.There is perforation 3mm of one anterior medial strut contacting the right common iliac artery.There is 2mm perforation of one posterior medial strut contacting the distal aorta at the bifurcation.There is 7mm perforation of one posterolateral strut contacting the anterior aspect of the right psoas muscle.Incidental findings included hypoattenuating lesion in the medial right lobe of the liver and a stent in the left common iliac.Almost two months after the scan, the patient was seen for right leg post thrombotic syndrome in the setting of a thrombosed ivc filter.A ct of the abdomen and pelvis venogram was performed and showed the filter in place just inferior to the renal veins; no acute thrombus was observed in the filter.Inferior to the filter it was noted the ivc is atretic from chronic thrombus.The common right iliac vein was not visualized, there is a very small right external iliac vein with multiple signs of chronic dvt.The left common iliac vein is compressed by the right common iliac artery at the junction with the ivc.The remainder of the left common iliac vein is stented and widely patent.Limited imaging of the femoral vein showed chronic dvt in the right femoral vein.Extensive venous collaterals primarily the right left femoral veins and between the right femoral and intercostal veins were also noted.Incidental findings included three hemangiomas in the liver, a large soft tissue mass in the uterus, suspicious for endometrial cancer.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.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and vessel characteristics.Collateral circulation is the result of normal blood flow pathways being obstructed and the body responds by creating new routes for the blood to circulate.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 tilt and perforation 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.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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, 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 tilting of the filter, perforation and subsequent blood clots.Per the medical records, the patient was reported to have a history of recurrent deep vein thrombosis (dvt).The patient underwent catheter directed thrombolytic therapy with stenting with concomitant placement of the inferior vena cava (ivc) filter.About sixteen years after the filter was implanted, the patient presented to the hospital with complaints of low back pain for a week and awoke the day of presenting with acute swelling, discoloration (blue) and pain of the right leg.The patient was not on anticoagulation at the time, and a doppler ultrasound of the right lower extremity indicated for leg pain revealed dvt within the right common femoral, superficial femoral and popliteal veins.The thrombus appeared to be extending to the posterior tibial veins as well as extending superiorly into the iliac vessels.The patient underwent venogram of the right popliteal vein and placement of a catheter for overnight tissue plasminogen activator (tpa).The indication was phlegmasia cerulea dolens of the right lower extremity, previous dvt, pulmonary embolism (pe) and ivc filter.The venogram showed extensive thrombus extending from the ivc filter all the way down into the right femoral venous system.The following day the patient underwent angiography and aspiration thrombectomy a massive amount of clot was removed from the ivc, the right iliofemoral system up to the filter.Clot could not be removed from the ivc filter.The patient was discharged three days later.Approximately sixteen years and seven months post implantation, an abdominal computerized tomography (ct) scan was indicated for filter evaluation.The scan reported an ivc filter in place; there is anterior tilt with the apex abutting the anterior wall of the inferior vena cava.The inferior tip extends into the proximal aspect of the right common iliac vein.The apex of the ivc filter is 5.5 cm below the renal veins.There is perforation of the anterior medial strut extending approximately 3mm beyond the wall of the inferior vena cava and contacting the right common iliac artery.There is perforation of the posterior medial strut extending approximately 2mm beyond the wall of the inferior vena cava and contacting the distal aorta at the bifurcation.There is perforation of the posterolateral strut extending approximately 7mm beyond the wall of the inferior vena cava and contacting the anterior aspect of the right psoas muscle.No strut fracture was noted.Incidental findings included hypoattenuating lesion in the medial right lobe of the liver.There is a stent in the left common iliac almost two months after the ct scan, the patient was seen for right leg post thrombotic syndrome in the setting of a thrombosed ivc filter.A ct of the abdomen and pelvis venogram was performed and showed the filter in place just inferior to the renal veins; no acute thrombus was observed in the filter.Inferior to the filter in the ivc, it was noted the ivc is atretic from chronic thrombus.The common right iliac vein was not visualized, there is a very small right external iliac vein with multiple signs of chronic dvt.The left common iliac vein is compressed by the right common iliac artery at the junction with the ivc.The remainder of the left common iliac vein is stented and widely patent.Limited imaging of the femoral vein showed chronic dvt in the right femoral vein.Extensive venous collaterals primarily the right left femoral veins and between the right femoral and intercostal veins were also noted.Incidental findings included three hemangiomas in the liver, a large soft tissue mass in the uterus, suspicious for endometrial cancer.The patient is known to have uterine fibroids and underwent ablation.A uterine biopsy was done for cancer two days later with negative results the patient was diagnosed with uterine fibroid.About six days post biopsy, the patient underwent a pelvic venogram and placement of a right iliac vein stent.The impression noted recanalization of a chronically occluded right common femoral vein using balloon dilatation and superimposed stents and slightly into the lower aspect of the ivc filter.Upon completion there was brisk flow and no significant residual narrowing.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, blood clots, clotting and occlusion of the ivc becoming aware of these events approximately sixteen years and seven months after the filter implantation, and further experienced anxiety related to the filter.
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