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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problem Pain (1994)
Event Date 11/24/2012
Event Type  Injury  
Manufacturer Narrative

A device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. An unknown inferior vena cava filter was deployed in the infra renal vein location without difficulty, for a patient with morbid obesity and in conjunction prior to bariatric surgery. Approximately six years and three months of post deployment, the patient presented with back pain. On the same day, a computed tomography (ct) abdomen and pelvis showed that there was a vena caval filter and the filter had migrated cephalad, when compared with the examination two years ago. In addition, 1 of the limbs of the filter was not directed cephalad and appeared to have been broken from the rest of the device. There was a second limb of the filter, which was also discontinuous and had broken from the rest of the device. The uppermost aspect of the cephalad directed limb lay at the level of the confluence of the right renal vein and inferior vena cava but did not projected above that level. After 3 days, the patient reported with migrated greenfield filter. After one week and two days, the patient presented with right lower quadrant abdominal pain. On the same day, a computed tomography (ct) scan demonstrated protruded arms of the inferior vena cava filter. There was limb fracture and perforation of the vena cava from the g2 inferior vena cava filter. The filter was also malpositioned. After two weeks and one day, an attempt was made to retrieve the fractured inferior vena cava filter from the patient¿s body. Multiple fractured limbs were noted in the imaging studies. Jugular vein was accessed with a large bore needle. Under fluoroscopic guidance, an extraction sheath was inserted. The g2 cone was used. Multiple attempts to capture the filter were unsuccessful. A snare was placed and multiple attempts to grab the tip of the cone were unsuccessful. The snare was pushed beyond the filter and a wire was inserted. This was then snared and pulled back, that grabbed the majority of the filter. Multiple attempts were made to pull the filter into the sheath; this was unsuccessful. The cone was again tried without success. After multiple attempts manipulated to remove the catheter tip and engage it in the cone, the procedure was aborted. After one month and one day, a computed tomography (ct) scan demonstrated that the filter was quite fragmented. The head of the filter was buried in the wall of the vena cava. One fragment of the filter detached and had worked its way along the lateral margin of the spine. Other legs of the filter were deeply penetrated into perivascular soft tissues in front of the spine, behind the aorta and between the aorta and cava. A fully detached fragment had come free of the filter and had lodged in the hepatic veins. After one week and one day, a computed tomography (ct) abdomen showed that the filter remained in stable position in the infra renal inferior vena cava. One of the metal legs of the filter was in an inappropriate position, that extended along the right lateral side of the l3 vertebral body. An additional limb of the filter extended medially under the abdominal aorta just above the bifurcation, which was also stable. After three weeks and six days, an ultrasound duplex upper extremity venous right showed no evidence of deep or superficial venous thrombosis in the right upper extremity. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter migration, filter limb detachment, filter malposition and retrieval difficulties. However, the investigation is inconclusive for material deformation. Based on the available information, the definitive root cause is unknown. 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.

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure. At some time post filter deployment, it was alleged that the filter migrated to heart, struts detached and perforated. The device has not been removed after an attempted but unsuccessful removal procedure. It was further reported that the detached struts retained in spine, vena cava and hepatic veins. The current status of the patient is unknown.

 
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Brand NameVENA CAVA FILTER
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 Key12179204
MDR Text Key261900794
Report Number2020394-2021-80569
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN FILTER
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
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: 07/16/2021 Patient Sequence Number: 1
Treatment
OMEPRAZOLE, XANAX, BUPROPION, PROZAC AND PREVACID
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