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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Great Vessel Perforation (2152)
Event Date 03/24/2005
Event Type  Injury  
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 for tilted filter and perforation of the ivc 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: - perforation of other acute or chronic damage of the ivc wall.- filter tilt - filter malposition.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 a vena cava filter was deployed and subsequently tilted.Approximately ten years post filter deployment a ct scan demonstrated the prongs of the filter extending outside the confines of the ivc.Approximately twelve years three months post filter deployment, during a scheduled retrieval procedure, it was discovered that the filter was embedded.The status of the patient is unknown.
 
Event Description
It was reported through the litigation process that a vena cava filter was deployed and subsequently tilted.Approximately ten years post filter deployment a ct scan demonstrated the prongs of the filter extending outside the confines of the ivc.Approximately twelve years three months post filter deployment, during a scheduled retrieval procedure, it was discovered that the filter was embedded.The status of the patient is unknown.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 and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted, perforated, and was embedded.The patient allegedly is experiencing pain in their left side, back, groin, and stomach.The device was removed percutaneously.The current status of the patient is unknown.
 
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 vena cava filter was deployed for history of right lower extremity dvt and prophylactically for orthopedic procedure.The deployed filter was placed via the left common femoral vein, in the infrarenal inferior vena cava with the tip of the filter located at the mid l2 vertebral body.Post venacavagram revealed the tip of the deployed filter to be against the right lateral wall of the vessel.There was an unsuccessful attempt to reposition the filter and unsuccessful transjugular attempt to remove the filter.Approximately ten years post filter deployment a ct scan of the abdomen revealed the prongs of the filter extending outside the inferior vena cava with one prong into the lumen of the aorta.Approximately eleven years six months post deployment the patient presented with intermittent pain.Approximately two weeks later a ct of the abdomen and pelvis revealed infiltration of prongs into the aorta, lumbar arteries, and possibly duodenum.Approximately twelve years three months post deployment patient presented for filter retrieval.Venagram indicated multiple filter legs outside the lumen of the vena cava.The right common femoral vein was accessed, an armada balloon was advanced and failed to snare the filter.Via the right internal jugular vein a modified loop snare technique was attempted resulting in an unsuccessful retrieval, bronchial forceps were then used resulting in successful retrieval of the intact filter device.Post retrieval venagram demonstrated patent inferior vena cava with no evidence of extravasation.Patient tolerated the procedure well.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Therefore, the investigation can be confirmed for filter tilt, filter limb perforation and retrieval difficulties based on the provided medical records.Per the medical records, post deployment venacavagram revealed tilted filter.An unsuccessful attempt was made to reposition the filter.Additionally, multiple unsuccessful attempts were made to retrieve the filter using armada balloon and loop snare techniques.Per the ifu, ¿if misplacement or sub-optimal placement of the filter occurs, consider immediate removal.Retrieve the recovery filter using the recovery cone system only.¿ therefore, attempts to reposition the filter could have contributed to the reported deficiencies.Additionally, attempts using snare devices likely contributed to retrieval difficulties.However, the definitive root cause is unknown.Labeling review: the current ifu(instructions for use) states : precautions: -if misplacement or sub-optimal placement of the filter occurs, consider immediate removal.Retrieve the recovery filter using the recovery cone system only.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.
 
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Brand Name
RECOVERY FILTER SYSTEM
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7389057
MDR Text Key104855841
Report Number2020394-2018-00326
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF048F
Device Lot NumberGFOI4314
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/28/2018
Initial Date FDA Received04/02/2018
Supplement Dates Manufacturer Received08/20/2018
Supplement Dates FDA Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OXYCODONE, PANTROPRAZOLE, KEFLEX; PERCOCET, TOPROL, COUMADIN, OXYCONTIN
Patient Outcome(s) Other;
Patient Age45 YR
Patient Weight69
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