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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Thrombosis/Thrombus (4440)
Event Date 11/19/2015
Event Type  Death  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Medical records review: the patient with deep vein thrombosis (dvt) and bleeding had a vena cava filter deployed. Approximately four months post filter deployment, the patient admitted to the hospital with a right leg dvt. The patient was scheduled for removal of the inferior vena cava (ivc) and right iliac vein thrombosis using angiovac with veno-veno extracorpeal membrane oxygenation (ecmo) and filter retrieval. Clot removal was started and the filter was easily removed. A good result was obtained at the end of the procedure with almost resolution of the clot in the ivc and the right iliac vein. Upon termination of the procedure and preparing to remove the cannulas, the patient became hypotensive, hypoxic, and had a pulseless electrical activity arrest. Cardiopulmonary resuscitation (cpr) was performed with good femoral pulse obtained. The circuit was quickly changed to an ecmo circuit with an oxygenator. A transesophageal echocardiogram (tee) showed the right ventricle (rv) to be dilated and with a mobile clot seen in the rv. A pulmonary arteriogram showed non-occlusive bilateral lower lobe branch pulmonary embolism. Once the patient was on the ecmo, cpr was stopped, saturations and blood pressure improved and the tee no longer showed the clot in the rv. The rv remained dilated but the left ventricle was normal. It was decided to keep the patient on ecmo and transfer to another facility for further critical care management. A bilateral lower extremity (le) ultrasound revealed right le swelling and right le dvt involving the popliteal and calf veins. A bilateral upper extremity ultrasound revealed bilateral cephalic vein thrombosis. Approximately one month post hospital admission, the patient expired. The cause of death was not provided. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. Based on the medical records, clot in the ivc was identified; however, the investigation is inconclusive for occlusion of the filter. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warning: - do not attempt to remove the denali filter if significant amount of thrombus are trapped within the filter or if the filter snare hook is embedded within the vena cava wall. Possible complications: - 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. - occlusion of small vessels. All of the above complications may be associated with serious adverse events such as medical intervention. 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 through the litigation process 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: 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. Approximately four months post filter deployment, during scheduled retrieval, it was alleged that the filter was thrombosed and the patient experienced cardiac arrest requiring cpr, intubation, and placement on bypass. It was further reported that approximately one month later, the patient expired. The cause of the patient's death was not provided.
 
Manufacturer Narrative
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. 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 through the litigation process 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.
 
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Brand NameDENALI FEMORAL SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key7131268
MDR Text Key106176138
Report Number2020394-2017-01775
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1
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