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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - FEMORAL; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 01/22/2016
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 11/2017).
 
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 and pulmonary embolism.Approximately four months post filter deployment, it was alleged that the filter migrated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced thrombus above the filter; however, the current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Eventually, after twelve days of post deployment, an ultrasound venous of the right lower extremity was revealed extensive deep vein thrombosis in the right leg.Subsequently, after one month, it was reported there was a thrombus around the inferior vena cava filter.Around, three months later, the patient was scheduled for the filter retrieval, the right neck was prepped.The inferior vena cava filter has migrated very significantly distally and was now lodged in the left common iliac vein.The common iliac vein on the left side was occluded.Because of the migration of the filter and the fact that there was thrombosis of the adjacent vein, the filter was not removed.Approximately, one year one month later, the patient was found to have developed extensive thrombosis of the inferior vena cava filter and the inferior vena cava was completely thrombosed with collaterals.Around, one month later, during the hospital visit, it was reported that the filter in place and apparently with thrombus on it.Approximately, ten months later, a computed tomography (ct) abdomen series with the chest was performed and it revealed an inferior vena cava filter was present with the tip located approximately at the l3 vertebral body level.Therefore, the investigation is confirmed for filter migration.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.Based on 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: d4 (expiry date: 11/2017), h11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.
 
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 and pulmonary embolism.Approximately four months post filter deployment, it was alleged that the filter migrated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced thrombus above the filter; however, the current status of the patient is unknown.
 
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Brand Name
G2 X 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 Key10681918
MDR Text Key211441979
Report Number2020394-2020-20114
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K082305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF400F
Device Lot NumberGFYJ3899
Was Device Available for Evaluation? No
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASPIRIN, XARELTO, GLUCOSAMINE AND MULTIVITAMINS; ASPIRIN, XARELTO, GLUCOSAMINE AND MULTIVITAMINS; ASPIRIN, XARELTO, GLUCOSAMINE AND MULTIVITAMINS
Patient Outcome(s) Life Threatening;
Patient Age43 YR
Patient Weight127
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