• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Thrombus (2101); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
Event Date 10/10/2012
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Medical record review: a patient with a history of deep vein thrombosis and pulmonary embolism with contraindication for anticoagulation, following a motorcycle accident with head injury was hospitalized. Approximately five days post hospital admission, the patient had a vena cava filter deployed. Approximately twenty days post filter deployment, the patient has a ct scan of the abdomen and pelvis, which noted a large thrombus within the inferior vena cava at the level of the filter, extending superiorly to the level of the right hepatic vein. In addition, there was venous thrombus within the right femoral vein and right external iliac vein. The patient was started on an anticoagulation drip and discharged one month later. Approximately two years seven months post filter deployment, the patient had a chest x-ray, which noted a wire-like object projected over the right hemithorax representing a retained filter fragment within the right lung or soft tissues. Approximately three years two months post filter deployment, the patient presented for filter retrieval. The filter and a detached filter limb embedded in the inferior vena cava were retrieved. No attempt was made to retrieve the detached filter limb in the lung. Investigation summary: approximately twenty days post filter deployment, the patient has a ct scan of the abdomen and pelvis, which noted a large thrombus within the inferior vena cava at the level of the filter, extending superiorly to the level of the right hepatic vein. Approximately two years and seven months post filter deployment, the patient had a chest x-ray, which noted a wire-like object projected over the right hemithorax representing a retained filter fragment within the right lung or soft tissues. Repeat anterior-posterior cavograms were performed which noted two fractured filter limbs. Therefore, the investigation is confirmed for the alleged detachment of filter limbs. It can also be confirmed that there was thrombosis above the filter after implantation. Based upon the available information, the definitive root cause is unknown. Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. 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 conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, allegedly filter limbs detached. The filter and a detached limb were removed percutaneously; however, a detached limb remains embedded in the lung. The current patient status is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7140216
MDR Text Key95555478
Report Number2020394-2017-01789
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,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received09/15/2021
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: 12/21/2017 Patient Sequence Number: 1
Treatment
COUMADIN
-
-