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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 Problems Malposition of Device (2616); Extrusion (2934)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2015
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Medical records review: the patient with history of deep vein thrombosis had an inferior vena cava filter deployed without complication. Approximately two years seven months post filter deployment, ct scan demonstrated an ivc filter with limbs extending beyond the ivc wall. The tip of the filter was at the level of the confluence of the left renal vein with the ivc. Approximately two years seven months post filter deployment, the patient was scheduled for filter retrieval. The right internal jugular vein was accessed and cavagram demonstrated evidence of endothelialization of the filter apex. The filter was loop snared and removed intact through the sheath. Visual inspection revealed six intact arms and six legs. The filter was sent to pathology. The patient tolerated the procedure well. Investigation summary: the device was not returned and images were not provided. Medical records were provided and reviewed. Based on the medical records, the investigation is confirmed for the alleged tilt and limb perforation. Based upon 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. The information provided by bard represents all of 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 bard.

 
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, it was alleged that the filter tilted and embedded in the wall of the ivc. The device was removed percutaneously. The 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7562589
MDR Text Key109892032
Report Number2020394-2018-00788
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 ATTORNEY
Type of Report Initial
Report Date 06/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK MERIDIAN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
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

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