Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. G2 EXPRESS 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. G2 EXPRESS FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2016
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2011).
 
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.Approximately eight years post filter deployment, a computed tomography (ct) scan revealed that the filter struts perforated.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.
 
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.Approximately eight years post filter deployment, a computed tomography (ct) scan revealed that the filter struts perforated.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.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and 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.Approximately eight years of post-deployment, computerized tomography lumbar spine demonstrated a retrievable vena cava filter at the level of l3.There was a leg penetration through the inferior vena cava 0.6 cm, behind the aorta.Around, eleven months later, computerized tomography-abdomen was revealed that tip off the vena cava filter was at the l3 vertebral body level.The inferior struts of the vena caval filter extended beyond the lumen of the inferior vena cava and particularly involved the medial and posterior struts of the vena cava filter.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 06/2011), g4.H11: h6 (results, conclusion).H11: section a through f: the information provide by bd represents all 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 bd.H3 other text : device not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
G2 EXPRESS FILTER SYSTEM - FEMORAL
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key11009868
MDR Text Key221493493
Report Number2020394-2020-20831
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K080668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF400F
Device Lot NumberGFSF0627
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received01/22/2021
Supplement Dates FDA Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age45 YR
-
-