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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 Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2014
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient with deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter occluded.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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient with deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter occluded.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.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, six years and seven months post filter deployment, the inferior vena cava filter was occluded with scar, large collaterals both cutaneous and mesenteric.Venoplasty of right femoral and external iliac veins was performed with good result.The common iliac and inferior vena cava was very hard and a straight glide complete total occlusion wire would not cross.Around, one month and four days later, angiogram was performed which showed that the filter was occluded with very impervious hard scar tissue.It could be crossed with cook cxi cath but with no reasonable iliac vein remains.Around, three years one month later, computed tomography of abdomen without contrast was performed which showed stenosis of the inferior vena at the level of inferior vena cava filter was likely due fibrosis.A contrast-enhanced study would offer more sensitive evaluation for inferior vena cava occlusion.Therefore, the investigation is confirmed for occlusion of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2010).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 - FEMORAL
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key12134379
MDR Text Key260455653
Report Number2020394-2021-01289
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 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF310F
Device Lot NumberGFRC2701
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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