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. RECOVERY FILTER SYSTEM; 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. RECOVERY FILTER SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 12/25/2017
Event Type  Injury  
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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral lower extremity lymphedema.Approximately eleven years and seven months later post filter deployment, it was alleged that the filter strut detached, perforated into organs and the patient reportedly experienced abdominal pain.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 bilateral lower extremity lymphedema.Approximately eleven years and seven months later post filter deployment, it was alleged that the filter strut detached, perforated into organs and the patient reportedly experienced abdominal pain.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 with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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 twelve years and seven months of post deployment, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was positioned below the level of renal veins.Some of the filter struts have penetrated through the wall of the inferior vena cava into the mesenteric fat.One of the arms penetrates into the aorta.A filter arm on the left side was fractured and was outside of the inferior vena cava lying adjacent to the aorta with its long axis parallel to the inferior vena cava.No filter tilt and migration were noted.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter limb detachment.Based on 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.H10: d4 (expiry date: 01/2008), g3, h6 (method).H11: h6 (result and conclusion).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RECOVERY FILTER SYSTEM
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key12187691
MDR Text Key262156852
Report Number2020394-2021-80577
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF048F
Device Lot NumberGFOL2716
Was Device Available for Evaluation? No
Date Manufacturer Received07/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACETAMINOPHEN AND ATORVASTATIN; ACETAMINOPHEN AND ATORVASTATIN; CLOPIDOGREL, HYDROXYZINE AND LISINOPRIL; CLOPIDOGREL, HYDROXYZINE AND LISINOPRIL; ACETAMINOPHEN AND ATORVASTATIN; CLOPIDOGREL, HYDROXYZINE AND LISINOPRIL
Patient Outcome(s) Other;
Patient Age59 YR
Patient Weight121
-
-