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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); Material Deformation (2976); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2015
Event Type  malfunction  
Manufacturer Narrative
Hospital/medical records were provided and reviewed.Medical images were provided and a review is currently underway.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient with history of hypercoagulable syndrome with need for surgery had a retrievable filter positioned and deployed below the renal veins with the apex in the renal vein inflow with no significant tilt.The procedure was completed without complication and the patient was transferred in stable condition.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 for hypercoagulable syndrome.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc and is unable to be retrieved.However, the device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
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 history of hypercoagulable syndrome with need for surgery had a retrievable filter positioned and deployed below the renal veins with the apex in the renal vein inflow with no significant tilt.The procedure was completed without complication and the patient was transferred in stable condition.Investigation summary: the device was not returned for evaluation.Images and medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Based on the image review, the investigation can be confirmed for tilt, perforation of the ivc, and material deformation.Per the medical records, the filter was deployed with the apex in the renal venous inflow.Per the instructions for use (ifu), "position the retrieval hook 1 cm below the lowest renal vein." however, 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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient for hypercoagulable syndrome.At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the ivc and is unable to be retrieved.However, the device has not been removed and 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 a vena cava filter was placed in a patient for hypercoagulable syndrome.At some time post filter deployment, it was alleged that the filter tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were provided and reviewed.Based on the medical records, approximately nine years eleven months post filter deployment, computed tomography revealed the filter was tipped such that its more superior portion passed through the anterior wall of the vena cava, while prongs of its posterior and lateral legs passed through the vena caval wall.One of the posterior legs actually extended several millimeters through the wall.Therefore, based on the medical records, the investigation is confirmed for perforation of the inferior vena cava (ivc).Based on the image review, anterior filter tilt, multiple filter limb perforation of the posterior, medial, and lateral ivc wall can be confirmed and two bent filter arms can be confirmed.Therefore, based on the image review, the investigation is confirmed for perforation of the inferior vena cava (ivc), material deformation and filter tilt.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), material deformation and filter tilt.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 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 Key7465781
MDR Text Key106797635
Report Number2020394-2018-00483
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 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
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 Received11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age41 YR
Patient Weight103
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