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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 Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2009
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately, two months five days of post deployment, the patient was diagnosed with deep vein thrombosis and pulmonary embolism with caval filter, now elected to have it removed. On the same day, the lumen was cannulated with a needle with fluoroscopic guidance to the inferior vena cava and a filter retrieval device catheter was placed. This was placed just above the filter and then a cavogram was obtained. The cavogram revealed there was no clot in this location; however, the tip of the catheter was right up against the wall. Multiple catheters were manipulated as well as wires to try to free the hook at the tip of the filter, but unsuccessful. The right femoral vein was anesthetized, placed a wire up this way and then blew up a balloon behind it. Despite the efforts, it appeared that the tip was not free for the passage of the snare. All the hardwares were removed. Around, seven years and five months later, the patient presented with flank pain. On the same day, axial images using computed tomography (ct) chest, abdomen and pelvis without intravenous contrast showed that filter limbs extended 1 cm beyond the lumen of the inferior vena cava, 1 fractured limb of the inferior vena cava filter was seen in the base of the right ventricle and 1 limb protruded into the right psoas muscle. There was no evidence of surrounding hematoma or tissue changes to suggest an acute event. Therefore, the investigation is confirmed for the filter limb detachment, perforation of the inferior vena cava (ivc) and retrieval difficulties. The definitive root cause could not be determined based upon available information. Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiry date: 08/2012).
 
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 with contraindication to anticoagulation. Approximately two months and five days post filter deployment, it was alleged that the filter was unable to retrieve, filter limbs extended beyond the lumen of the inferior vena cava and a fractured strut was seen in the base of the right ventricle. The device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The current status of the patient is unknown.
 
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Brand NameG2 X FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11573897
MDR Text Key242395237
Report Number2020394-2021-00700
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400F
Device Lot NumberGFTG2532
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/26/2021 Patient Sequence Number: 1
Treatment
LISINOPRIL, DULOXETINE, BUSPAR; LOVENOX; RANITIDINE HYDROCHLORIDE, XYZAL, COUMADIN
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