|
Catalog Number MD800J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Death (1802); Thrombosis (2100); Blood Loss (2597)
|
Event Type
Death
|
Manufacturer Narrative
|
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.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.
|
|
Event Description
|
It was reported that some time post vena cava 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.
|
|
Manufacturer Narrative
|
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 event reported to date for this lot number and failure mode.Medical record review: a patient presented for an inferior venacava filter placement due to a history of deep vein thrombosis and at high risk for dvt.Imaging demonstrated the left and right common femoral veins to be occluded with a large amount of firm thrombus.An inferior venacavogram demonstrated the ivc to be widely patent, of normal caliber with no evidence of aberrant venous anatomy.A vena cava filter was successfully deployed via the internal jugular vein and placed below the level of the renal veins.Post venacavogram demonstrated the filter to be well centered with a widely patent cava.The patient tolerated the procedure well with no complications.Approximately two weeks post filter deployment the patient presented to the hospital with weakness, decreased level of consciousness, acute renal failure, acute encephalopathy, anemic, thrombocytopenia, altered mental status and chest pain.Patient terminated that same day.Medical records indicated cause of death as sepsis and stage 4 cholangiocarcinoma.Medical death summary states the patient had a history of dvt status post ivc filter placement, location and date of occurrence not provided.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 03/2014), (manufacturing date: 03/2013), (patient code).(product catalog no., corporate lot no).
|
|
Event Description
|
It was reported that some time post vena cava 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 placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the device was unable to be retrieved and failed to stop blood clot.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced internal bleeding, however, the patient expired.
|
|
Search Alerts/Recalls
|
|
|