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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2017
Event Type  malfunction  
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 tilt and perforation 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 sometime post filter deployment, the filter allegedly tilted and perforated the inferior vena cava.There were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for tilt and perforation 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.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 sometime post filter deployment, the filter allegedly tilted and perforated the inferior vena cava.There were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a device history review could not be performed as the lot number is unknown.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 nine years and one month later, computed tomography (ct) revealed that there was apparent extension of the distal aspect of the legs beyond the inferior vena cava lumen.3.8 degree of medial tilt was noted.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava (ivc).However, the investigation is unconfirmed for alleged filter tilt as medical record states that "3.8 degree of medial tilt was noted".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.H10: b5, g3, g4 h11: d1, d4(product catalog no), h6(results, conclusion) 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.
 
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 the filter tilted and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
 
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Brand Name
G2 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 Key7664925
MDR Text Key113266037
Report Number2020394-2018-01107
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF310F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ZITHROMAX, LORTAB, VITAMINS, AND LOVENOX
Patient Age35 YR
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