• 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 Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 11/20/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. Approximately two years and one-month post filter deployment, the patient experienced abdominal pain and a left lower extremity pain. On the same day, computed tomography performed revealed inferior vena cava filter was in place. After ten months and six days later, computed tomography revealed the superior extent of inferior vena cava filter was at mid l2 vertebral body and inferior extent at inferior l3 vertebral body, positioned within 1 cm of the renal veins. A total of 6 prongs had perforated the inferior vena cava. Maximum distance prongs perforated was 2 mm. This was most significant, where the tine abutted the surface of the infrarenal abdominal aortic aneurysm. Coronal images showed 1-degree tilt right-to-left and sagittal images showed 4-degrees tilt anterior to posterior. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc). However, the investigation is unconfirmed for filter tilt as the medical records state ¿coronal images showed 1-degree tilt right-to-left and sagittal images showed 4-degrees tilt anterior to posterior. ¿ 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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with unknown medical complication. At some time post filter deployment, it was alleged that the filter tilted and struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly experienced abdominal pain; however, the current status of the patient 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 Key11364069
MDR Text Key233013265
Report Number2020394-2021-80184
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
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 Received01/27/2021
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: 02/23/2021 Patient Sequence Number: 1
Treatment
ALPRAZOLAM, PROSCAR, FUROSEMIDE AND PLAVIX; PREDNISONE, PHENERGAN, LISINOPRIL AND PROTONIX; TAMSULOSIN, ASPIRIN, MUCINEX AND ONDANSETRON; ZITHROMAX AND NORCO
-
-