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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Positioning Problem (3009); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2019
Event Type  Death  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. 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. Bard meridian filter was deployed at the l2 vertebral body and good position with full expansion and minimal tilt in a patient with deep vein thrombosis. Approximately four years and eleven months of post deployment, computerized tomography-abdomen was performed which showed that inferior vena cava tip was noted just above the level of the left renal vein on image 67/5, and above the right renal vein by approximately 8 mm. There were several components which appeared to be outside of the inferior vena cava anteriorly by 3 mm, adjacent to the duodenum. Posteriorly this component was outside of the inferior vena cava on image 85/601 and was adjacent to an osteophyte of the vertebral spine. The foot component appeared to be 2 to 3 mm medial to the inferior vena cava adjacent to the aorta on image 61/602 of the coronal imaging. On axial imaging there was redemonstration of the above findings, and there was a posterior foot component however was felt to be the confines of the inferior vena cava. Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc) and positioning issue. 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. Expiry date: 07/2014.
 
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. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient subsequently expired.
 
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Brand NameMERIDIAN 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 Key12126949
MDR Text Key260203707
Report Number2020394-2021-80543
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112497
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 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMD800F
Device Lot NumberGFXF3366
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2013
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: 07/07/2021 Patient Sequence Number: 1
Treatment
CALCIUM WITH VITAMIN D, CITALOPRAM; CELEXA, TRAMADOL, COLACE, FLONASE, MIRALAX; LEVOTHYROXINE, PHENERGAN; LIPITOR, ZETIA, LOVENOX, COUMADIN, DESYREL; MAGNESIUM/POTASSIUM, ATORVASTATIN; PREDNISONE, CALCIUM CARBONATE, MAGNESIUM OXIDE; ZOFRAN, PROTONIX, CLARITIN
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