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Model Number 466P306X |
Device Problems
Failure to Align (2522); Defective Device (2588)
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Patient Problems
Embolus (1830); Occlusion (1984); Perforation (2001); Perforation of Vessels (2135)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and perforation abutting and adjacent organ.The indication for the filter implant has 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 trapease 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.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 perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without post implant images available for review the reported perforation, perforation abutting, and adjacent organ 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, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation and perforation abutting and adjacent organ.
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Event Description
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Additional information received per the medical records indicate that the patient has a history of acute chronic deep vein thrombosis with contraindication to anticoagulation.The filter was deployed via the patient's right common femoral vein.The filter was positioned at the l2 level.A post procedural inferior vena cavogram showed good flow past the filter and the filter to be in a satisfactory position.The patient tolerated the procedure well. additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient continues to experience anxiety and worry related to the filter.The patient became aware of the reported events eight years and two months after the index procedure.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, b7, d11, g3, g4, g7, h1, h2 and h6.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and perforation abutting and adjacent organ.The patient reported becoming aware of filter tilt, perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc approximately eight years and two months post implant.The patient also reported anxiety related to the filter.According to the implant record the indication for the filter implant was acute on chronic deep vein thrombosis with a contraindication to anticoagulation, not specified.The filter was placed via the right common femoral vein and deployed with the tip at the level of l2.A post procedural inferior vena cavogram showed good flow past the filter and the filter to be in a satisfactory position.The patient tolerated the procedure well.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 trapease 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.Blood clots, clotting and/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry, technique 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 event.Without post implant images available for review the reported events could not be confirmed or further clarified.Anxiety does nor 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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Search Alerts/Recalls
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