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 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 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2018
Event Type  Death  
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.Medical records were not provided.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.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 some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
 
Manufacturer Narrative
H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eight years and eleven months of post deployment, computed tomography of abdomen was performed, and result showed that a bard inferior vena cava filter was noted below the renal veins with its tip at the level of l2-l3.Some of the filter struts have penetrated 20 mm through the wall of the inferior vena cava into the pericaval or mesenteric fat.The filter was tilted right with its proximal cone lay on the wall of the inferior vena cava possibly embedded in it.Only 11 total struts were seen.There should be a total of 12.One strut was missed which represent a fracture with migration of the missed strut.Therefore, the investigation is confirmed for filter tilt, perforation of inferior vena cava (ivc) and filter limb detachment.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.H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported through the litigation process that some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
G2 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 Key10147627
MDR Text Key194923031
Report Number2020394-2020-03936
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF310F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COUMADIN
Patient Outcome(s) Death;
Patient Age62 YR
Patient Weight100
-
-