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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 Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2016
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.

 
Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with pulmonary embolism. Approximately two years three months post filter deployment, inferior venogram was performed, it revealed that the filter tilted. Approximately two years ten months post filter deployment, inferior vena cava and bilateral iliac vein duplex exam was performed, it revealed that the filter migrated. 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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key10703503
MDR Text Key212072914
Report Number2020394-2020-20163
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,Followup
Report Date 12/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMD800F
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 Received12/30/2020
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: 10/20/2020 Patient Sequence Number: 1
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