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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 Problem Malposition of Device (2616)
Patient Problem Death (1802)
Event Date 05/31/2011
Event Type  Death  
Manufacturer Narrative
Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical records were provided and reviewed.Approximately four months post deployment, filter was tilted laterally and posteriorly to the right.And it was reported that the patient expired.Therefore, the investigation is confirmed for 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.Medical device - expiry date: 06/2013.
 
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 laterally and posteriorly to the right.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.
 
Manufacturer Narrative
Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately after four months four days, an air upper gastrointestinal with scout x-ray revealed that an inferior vena cava filter tilted laterally and posteriorly to the right.Based on medical records review, death certificate or information regarding the cause of death was not provided for this patient.Therefore, the investigation is confirmed for 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.
 
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 laterally and posteriorly to the right.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.
 
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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 Key9133562
MDR Text Key160488991
Report Number2020394-2019-03618
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
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF310F
Device Lot NumberGFUE4483
Was Device Available for Evaluation? No
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATENOLOL, COLACE, LASIX, LORTAB AND; MIRALAX AND K-DUR
Patient Outcome(s) Death;
Patient Age84 YR
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