CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number 466FXXXX |
Device Problem
Fracture (1260)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/01/2021 |
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, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had fractured.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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 procedural films for review, the reported filter fracture could not be confirmed and the exact cause could not be determined.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.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.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 including, but not limited to filter fracture.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.
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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 filter fracture.The patient reported becoming aware of the event approximately eight years post implant.The patient also reported experiencing breathing difficulty, lower abdominal pain, back pain, headaches and swelling of the legs post implant, and anxiety related to the filter.According to the implant record the indication for the filter implant was left deep vein thrombosis (dvt) extending from the left posterior tibialis veins up to the bifurcation of the common iliac vein and was reported to have a history of chronic anemia and fibroid tumors.The filter was placed via the right femoral vein and inserted, without complications, after abdominal angiography was performed.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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 procedural films for review, the reported filter fracture could not be confirmed, and the exact cause could not be determined.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.Breathing difficulty, lower abdominal and back pain, headaches, leg swelling and anxiety do not represent a device malfunction and may be related to underlying patient specific issues, such as the patients¿ medical history.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.
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Event Description
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Per the implant records, the patient presented with left deep vein thrombosis (dvt) extending from the left posterior tibialis veins up to the bifurcation of the common iliac vein and was reported to have a history of chronic anemia and fibroid tumors.The filter was indicated due to severe dvt.The patient¿s right groin was prepped and draped using sterility.Access to the right femoral vein was obtained using seldinger technique.A sheath was inserted in the right femoral vein followed by a catheter and an abdominal angiography was completed.The optease vena cava filter was inserted.There were no reported complications.According to the information received in the patient profile form (ppf), the patient reports fractured filter struts retained within the inferior vena cava (ivc), becoming aware of these events approximately eight years after the filter implantation.The patient further asserts to have experienced breathing difficulty, lower abdominal pain, back pain, headaches and swelling of the legs post implant, in addition to anxiety related to the filter.
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