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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 Problem Malposition of Device (2616)
Patient Problem Thrombus (2101)
Event Type  Injury  
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. Sometime post filter deployment, computed tomography revealed inferior vena cava thrombus extended up to 1. 8 cm superior to the superior aspect of the inferior vena cava filter. Approximately three years post filter deployment, computed tomography revealed inferior vena cava filter with an abnormal oblique orientation in relation to the inferior vena cava which measured approximately 35 degrees. Therefore, the investigation is confirmed for filter tilt. Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment. However, the relationship to the filter is unknown. 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. (expiry date: 04/2015).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient to prevent blood clots from traveling. At some time post filter deployment, it was alleged that the filter tilted. 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 - 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 Key10348675
MDR Text Key201147920
Report Number2020394-2020-05217
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112497
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 07/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMD800F
Device LOT NumberGFYC3758
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/28/2014
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: 07/31/2020 Patient Sequence Number: 1
Treatment
COUMADIN, ESTROGEN, METOPROLOL, IRON, OMEPRAZOLE; LIDOCAINE, FERROUS SULPHATE, COLACE, COMPAZINE; NORVASC, FENTANYL, MORPHINE AND LOVENOX; ROCEPHIN, FLAGYL, CEFTRIAXONE, DILAUDID, REGLAN; ZOFRAN, PROTONIX, PHENERGAN, SODIUM CHLORIDE
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