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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/18/2017
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not performed as the lot number was not provided.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: 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 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
A manufacturing review was not performed as the lot number was not provided.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.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 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 record 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 eight years and seven months later, computerized tomography-abdomen without contrast was performed which showed that an inferior vena cava filter was infrarenal location with sub le lateral tilting.The tips of the prongs of the inferior vena cava filter appeared to extend be on the inferior vena cava lumen.Therefore, the investigation is confirmed for alleged filter tilt.However, the investigation is inconclusive for alleged perforation of the inferior vena cava.Based on the provided medical records perforation of the inferior vena cava cannot be confirmed as the record states ¿the tips of the prongs of the inferior vena cava filter appeared to extend be on the inferior vena cava lumen".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.
 
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 inferior vena cava.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 - JUGULAR
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7659910
MDR Text Key113070469
Report Number2020394-2018-01088
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K052578
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 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF320J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASPIRIN, CLONIDINE, SENNA-S/DOCUSATE/SENNA; CATAPRES, CRESTOR, DIOVAN, FISH OIL, ZYRTEC; DULCOLAX, NITROSTAT, CLINDAMYCIN; ENOXAPARIN, HYDROXYZINE, CETIRIZINE/ZYRTEC,; NITROGLYCERIN, NIFEDIPINE XL,; OMEGA-3/POLYUNSATURATED FATTY ACID/FISH OIL,; OXYCONTIN, PRILOSEC,; POLYETHYLENE GLYCOL/MIRALAX,; ROSUVASTATIN/CRESTOR,; SERTRALINE/ZOLOFT, SOTALOL,; VALSARTAN/DIOVAN, BETAPACE; WARFARIN/COUMADIN, ACETAMINOPHEN/HYDROCODONE/NORCO
Patient Age74 YR
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