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Model Number 466FXXXX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Perforation (2001); Perforation of Vessels (2135)
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Event Date 05/25/2021 |
Event Type
Injury
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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 filter perforation.The indication for the filter implant, procedural details and medical history of the patient have not been provided and there is currently no additional information available for review.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.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.Without images available for review the reported events could not be confirmed or 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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As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter perforation.As a direct and proximate result, 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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After further review of additional information received.As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.The filter was implanted via the left groin without incident.Approximately eight years and three months after the filter implantation, the patient became aware that filter struts had perforation outside the inferior vena cava (ivc).The patient further reported having experienced depression and left inner thigh and right calf pain associated with the filter.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the 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 images or procedural films for review, the reported ivc perforation could not be confirmed and the exact cause could not be determined.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The depression experienced by the patient does not represent a device malfunction.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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Additional information received per the medical records state that the filter was deployed via the patient's left groin.The procedure was completed without incident. additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported event approximately eight years and three months after the index procedure.The patient also experienced depression, constant left inner thigh pain and right calf pain.The pain is worse at night and the patient has to take medication to sleep (trazodone).
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Search Alerts/Recalls
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