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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Thrombus (2101)
Event Date 12/25/2016
Event Type  Injury  
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 complaint reported to date for this lot number and failure mode.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: 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.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 approximately six years eleven months post vena cava filter deployment the patient was admitted to the hospital and diagnosed with pulmonary embolism.Three days later, a ct scan of the abdomen reportedly demonstrated a displaced filter with multiple limbs extending outside the vena cava and some occlusive clot above the filter up to the hepatic veins.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
Event Description
It was reported through the litigation process that approximately six years eleven months post vena cava filter deployment the patient was admitted to the hospital and diagnosed with pulmonary embolism.Three days later, a ct scan of the abdomen reportedly demonstrated a displaced filter with multiple limbs extending outside the vena cava and some occlusive clot above the filter up to the hepatic veins.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
Manufacturer Narrative
H10: 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.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately six years post filter deployment, computed tomography revealed bilateral pulmonary embolism.Approximately three days later, computed tomography revealed infrarenal inferior vena cava filter with multiple legs were extending slightly out of the inferior vena cava, including one which extended into the lumen of the adjacent abdominal aorta.The external iliac veins, common iliac veins and inferior vena cava inferior to the filter were dilated with minimal venous blood flow present suggesting that they were largely occluded.There also was poor opacification of the inferior vena cava just above the filter to the level of the renal veins suggesting nearly occlusive thrombus.Probable partially occlusive thrombus in the inferior vena cava from the level of the renal veins to the hepatic veins.A prominent anterior spur was at l4-5 abuts the posterior margin of the inferior vena cava at the level of the inferior vena cava filter.Approximately two years later, computed tomography revealed inferior vena cava filter was noted in place.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt.Additionally, it can be confirmed that the patient experienced pulmonary embolism and thrombus above the filter post deployment.However, the relationship to the filter is unknown.Based upon 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.H11:section a through f - the information provided by bd 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 bd.
 
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Brand Name
G2 X FILTER SYSTEM - FEMORAL
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7606812
MDR Text Key111231930
Report Number2020394-2018-00896
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K082305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2012
Device Catalogue NumberRF400F
Device Lot NumberGFTI3852
Was Device Available for Evaluation? No
Date Manufacturer Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other;
Patient Age63 YR
Patient Weight89
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