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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 Problems Positioning Problem (3009); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problem Abdominal Pain (1685)
Event Date 09/13/2010
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown. Investigation summary:the device was not returned for evaluation. Medical records were provided and reviewed. The medical records allege bard g2 filter was implanted in the l3 level location for a patient. Unfortunately, the filter immediately turned sideways, and the deployment wire appeared to catch one of the legs of the filter. The filter was deployed at l3 level but appeared to migrate up in interspace up around the l2 region after attempt to dislodge the delivery system from the filter. The filter remained in a sideways position and appeared to be lodged at the area of the right renal vein and well below the left renal vein. The filter appears to be located horizontally. After two days, dx abdomen one view revealed the filter was oriented in transverse manner. Radiographic impression revealed the filter was transverse orientation at the l1-l2 level. After five months, through the right femoral vein access, a bard eclipse filter was successfully deployed just below the previously placed filter at l3 level for a patient. On the same day, inferior vena cava x-ray revealed the first filter tip was pointed inferiorly and to the left. It was obliquely positioned in relation to the inferior vena cava. Injection of the inferior vena cava reveals some of the tines of the filter had superior to the inferior vena cava. There was no clot within the filter. Some of the filter tines pierced the inferior vena cava. The more cephalad filter had some of the struts projected within the right renal vein. The second filter appears to be properly oriented. The patient experienced abdominal pain. Therefore, the investigation is confirmed for the alleged positioning issue, filter migration and perforation of the inferior vena cava. 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.

 
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. During deployment, it was alleged that the filter tilted and migrated. At some time post filter deployment, it was alleged that the struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

 
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Brand NameG2 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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key12073453
MDR Text Key258633578
Report Number2020394-2021-80529
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
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: 06/28/2021 Patient Sequence Number: 1
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