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no medical records were provided to the manufacturer.Photos were provided for review.The lot number for the device was provided.The device history record review was completed.The device has been returned.The investigation is currently under way.The catalog number identified has not been cleared in the us, but is similar to the denali vena cava filter products that are cleared in the us.The pro code and 510 k number for the denali vena cava filter products are identified respectively.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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It was reported that the patient was in cardio pulmonary arrest upon arrival, a jugular deployment of a vena cava filter was performed.It was further reported that the sheath allegedly was positioned in the ovarian vein and the filter was partially deployed.Reportedly, the health care provider used the sheath and a snare device to capture the filter and move it into the ivc.Following deployment of the filter in the ivc, a j-tipped guidewire was inserted to adjust the filter when it was allegedly discovered that the filter had migrated into the right atrium as demonstrated by guided fluoroscopy.The patient underwent a thoracotomy to surgically remove the filter.The patient status post procedure was unknown.
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It was reported that the patient was in cardio pulmonary arrest upon arrival, a jugular deployment of a vena cava filter was performed.It was further reported that the sheath allegedly was positioned in the ovarian vein and the filter was partially deployed.Reportedly, the health care provider used the sheath and a snare device to capture the filter and move it into the ivc.Following deployment of the filter in the ivc, a j-tipped guidewire was inserted to adjust the filter when it was allegedly discovered that the filter had migrated into the right atrium as demonstrated by guided fluoroscopy.The patient underwent a thoracotomy to surgically remove the filter.The patient status post procedure was unknown.
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Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Labeling review: the current ifu (instructions for use) states: warning: - do not deploy the filter prior to proper positioning in the ivc, as the denali® vena cava filter cannot be safely reloaded into the storage tube.Do not deploy the filter unless ivc has been properly measured.Never re-deploy a removed filter.- delivery of the denali filter through the introducer sheath is advance only.Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath - care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided.- do not deliver the filter by pushing it beyond the end of the introducer sheath.To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath.Do not twist the pusher handle at anytime during this procedure.- movement, migration or tilt are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration.Migration may be caused by placement of the filter in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.Precautions: -position the filter snare hook 1cm below the lowest renal vein.Venacavography must always be performed to confirm proper implant site.Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading.-if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.- it is very important to maintain introducer patency with a saline flush to prevent occlusion of the introducer, which may interfere with delivery device advancement.- care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided.- do not deliver the filter by pushing it beyond the end of the introducer sheath.To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath.Do not twist the pusher at anytime during this procedure.Potential complications: - movement, migration or tilt are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration.Migration may be caused by placement of the filter in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.Investigation summary: one denali filter was returned for evaluation.Two digital photos were also provided for review.The returned device had three limbs bound together by clot.Clot was also noted to be surrounding the apex of the device.No anomalies were noted to the returned device when the clot was removed.Therefore, the investigation is inconclusive for the alleged positioning issue, use of device issue, and migration issue.Per the reported event details, the filter was initially deployed in the ovarian vein.The denali filter is only intended for deployment in the inferior vena cava.Per ifu, "position the filter snare hook 1cm below the lowest renal vein.Venacavography must always be performed to confirm proper implant site.Radiographs without contrast, which do not clearly show the wall of the ivc, may be misleading." additionally, the filter was than repositioned after deployment.Per ifu, "if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter." therefore, use related issues most likely contributed to the incorrect positioning of the filter and the migration of the filter to the heart.
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