• 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 Migration or Expulsion of Device (1395); Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately thirteen years and one-month post filter deployment, the patient evaluated the filter while they are experiencing back pain.In patient history, computed tomography (ct) revealed the filter was already partially protruding outside the inferior vena cava.After one month later, computed tomography (ct) revealed the tip of the inferior vena cava filter was seen inferior to the right renal vein and the limbs of the filter extend outside the wall of the inferior vena cava to the surrounding fat.The inferior aspect of the inferior vena cava filter was seen almost at the level of bifurcation.The inferior vena cava filter had punctured and moved.After one month and seven days later, the patient scheduled for filter retrieval.A 12 french cook filter retrieval sheath that was advanced over an amplatz wire just above the inferior vena cava filter.Various attempts to place the snare over the tip of the filter was failed due to the left lateral position of the filter.10 x 40 mm dorado balloon on the left side of the filter over a wire and push it slightly towards the middle of the inferior vena cava to grasp the filter with snare and it could not get into the coaxial sheath retrieval system.By repositioning the balloon from the groin was finally able to align the filter and get it into the sheath.At this stage, it started to constrict the filter however it was attached firmly to the right wall of the inferior vena cava.Therefore, the procedure was stopped.The completion cavagram demonstrated good flow through the inferior vena cava without thrombosis.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and retrieval difficulties.However, the investigation is inconclusive for filter migration.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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts perforated.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The patient reportedly expired.
 
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
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 Key10182797
MDR Text Key196045782
Report Number2020394-2020-04025
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF048F
Device Lot NumberGFOE0993
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/02/2020
Initial Date FDA Received06/23/2020
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 Sequence Number1
Patient Outcome(s) Death;
-
-