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Catalog Number EC500F |
Device Problems
Extrusion (2934); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Death (1802); Great Vessel Perforation (2152)
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Event Type
Death
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Manufacturer Narrative
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No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records is not being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
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Event Description
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It was reported that some time post filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death, the cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
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Manufacturer Narrative
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Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned.Images and medical records were not provided.There was no specific deficiency alleged.The investigation is inconclusive.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: possible complications include, but are not limited to, the following: movement, migration or tilt of the filter 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 of the filter.Migration may be caused by placement 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; filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Detachment of components; perforation or other acute or chronic damage of the ivc wall; acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels; deep vein thrombosis; caval thrombosis/occlusion; extravasation of contrast material at time of venacavogram; air embolism; hematoma or nerve injury at the puncture site or subsequent retrieval site; hemorrhage; restriction of blood flow; occlusion of small vessels; distal embolization; infection; intimal tear; stenosis at implant site; failure of filter expansion/incomplete expansion; insertion site thrombosis; filter malposition; vessel injury; arteriovenous fistula; back or abdominal pain; filter tilt; hemothorax; organ injury; phlegmasia cerulea dolens; pneumothorax; postphlebitic syndrome; stroke; thrombophlebitis; venous ulceration; blood loss; guidewire entrapment; pain.All of the above complications may be associated with serious adverse events such as medical intervention and/or death.(b)(4).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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Event Description
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It was reported that some time post filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death, the cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
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Manufacturer Narrative
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Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Medical records review: the patient with a history of deep vein thrombosis and hematuria on anticoagulation presented to the hospital subsequent to acute venous embolism and thrombosis of unspecified deep vessels of lower extremity.Placement of a vena cava filter was indicated due to inability to be anticoagulated for upcoming ureteroscopy.The right femoral vein was accessed and imaging demonstrated a circumaortic left renal vein.The inferior vena cava (ivc) was found to be patent with no intraluminal filling defects to suggest thrombus.The filter was deployed into the infrarenal vena cava.A completion inferior vena cavogram was acquired and confirmed satisfactory positioning of the filter in the infrarenal position.The patient underwent an ureteroscopy, nine days later.Two days post ureteroscopy, the patient complained of severe right leg pain before going into the bathroom and collapsing.The patient was pronounced deceased a short time later at the emergency department.The autopsy demonstrated multiple bilateral acute pulmonary emboli; diffuse pulmonary edema throughout both lungs; deep venous thrombosis to right femoral, popliteal, and posterior tibial veins; and one small thrombus adhering to the filter.Additionally, examination of the ivc noted multiple patterned, tandem intimal tears to the ivc consistent with trauma from the "legs" of the filter (possible postmortem artifact).The immediate cause of death per the death certificate was determined to be acute pulmonary emboli due to deep venous thrombosis.Investigation summary: the device was not returned and images were not provided for review.However, medical records were provided and reviewed.Approximately eleven days post filter deployment, the patient was pronounced deceased at the emergency department.The autopsy demonstrated multiple bilateral acute pulmonary emboli; diffuse pulmonary edema throughout both lungs; deep venous thrombosis to right femoral, popliteal, and posterior tibial veins; and one small thrombus adhering to inferior vena cava filter.Additionally, examination of the inferior vena cava noted multiple patterned, tandem intimal tears to the inferior vena cava consistent with trauma from the "legs" of the filter.Therefore, based on the provided medical records, the investigation can be confirmed for perforation of the ivc wall by filter limbs.It can also be confirmed that the patient experienced pe after filter implantation.However, the origin of the pe and the relationship to the filter has not been established.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: possible complications include, but are not limited to, the following: - perforation or other acute or chronic damage of the ivc wall.- acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.All of the above complications may be associated with serious adverse events such as medical intervention and/or death.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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Event Description
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It was reported that some time post filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death, the cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.New information received: it was reported through the litigation process that a vena cava filter was deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and for a ureteroscopy.At some time post filter deployment, it was alleged that filter strut(s) perforated into organs.It was further alleged that the patient experienced a pulmonary embolism.Subsequently, the patient expired.
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Search Alerts/Recalls
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