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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2X FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problem Pulmonary Embolism (1498)
Event Date 07/12/2016
Event Type  Injury  
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 pulmonary embolism (pe) and lower extremity deep vein thrombosis (dvt) had a vena cava filter deployed in an infrarenal position at the level of l2-l3. Approximately five years and four months post filter deployment, the patient was admitted for bilateral lower extremity dvts and right lower lobe pe that was demonstrated on doppler and a chest computed tomography (ct) scan. A ct scan of the abdomen performed to evaluate the filter demonstrated a functioning filter with caval perforation/penetration that was deemed to be clinically irrelevant. The patient was started on anticoagulation and discharged the following day. Investigation summary: the device was not returned for evaluation and images were not provided for review. However, medical records were provided and reviewed. Based on the medical records, the investigation is confirmed for perforation of the inferior vena cava. It can also be confirmed that the patient experienced pe after filter implantation; however, the origin of the pe and the relationship to the filter is unknown based on the provided medical records. Additionally, the investigation is inconclusive for detachment of filter limbs. 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 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 filter strut(s) perforated into organs and a detached limb is in one of the lungs. The device has not been removed and there were no reported attempts made to retrieve the filter or the detached limb. Reportedly, the patient experienced pulmonary embolism and deep vein thrombosis sometime post filter implant; however, the status of the patient is unknown.

 
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Brand NameG2X FILTER SYSTEM - FEMORAL
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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7546175
MDR Text Key109353144
Report Number2020394-2018-00736
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 05/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400F
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2018
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: 05/25/2018 Patient Sequence Number: 1
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