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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number UNK MERIDIAN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
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. Approximately two months of post deployment, a computed tomography abdomen pelvis showed extensive ilio-caval deep vein thrombosis extending from the common femoral veins through the infra renal inferior vena cava, extending above level of apex of inferior vena cava filter by approximately 1. 5 cm. Five days later, the patient presented with abdominal pain and the next day, the patient developed acute low back pain. Four days later, an x-ray abdomen kub scan showed the filter at the l2-l3 level. One year and eleven months later, an x-ray abdomen kub scan showed an appropriately positioned inferior vena cava filter. One year and eleven months later, a vq scan showed the presence of a newly developed pulmonary embolism. One year and two months later, a nm ventilation perfusion scan demonstrated intermediate likelihood ratio for pulmonary embolism, mostly due to suboptimal ventilatory imaging. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Additionally, it can be confirmed that the patient experienced pulmonary embolism and 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.
 
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, the patient was reportedly diagnosed with thrombus above the filter and pulmonary embolism. 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.
 
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Brand NameMERIDIAN FILTER SYSTEM
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 Key11900021
MDR Text Key253133881
Report Number2020394-2021-80471
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
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 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK MERIDIAN
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 Received05/03/2021
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: 05/28/2021 Patient Sequence Number: 1
Treatment
COUMADIN AND LOVENOX
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