• 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. ECLIPSE 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. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 07/31/2018
Event Type  Injury  
Manufacturer Narrative
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 six years and nine months later, computed tomography of the abdomen without contrast revealed the superior tip lies about 2. 0 cm inferior to the level of the right and left renal veins. The axis of the filter was tilted such that the superior end was tilted rightward about 16 degree all and anteriorly about 9 degree. The filter itself appears intact and specifically no fractured struts. The inferior tips of the 6 longer struts extend about a cm beyond the wall of the inferior vena cava. The strut projecting toward the left protrudes into the wall of the abdominal aorta but no surrounding fluid collection or inflammatory changes. Unknown scan revealed, displaced filter with legs through the inferior vena cava. After seven months, the patient presented filter removal, right internal jugular vein was accessed percutaneously. The long 10 french sheath was placed down into the inferior vena cave over a wire. The filter was snared and then pulled up into the 10 french sheath which was then removed. Therefore, the investigation is confirmed for the alleged filter tilt and perforation of the inferior vena cava. 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 trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter tilted and struts perforated the inferior vena cava wall. The device was removed percutaneously. The patient experienced pain at the inferior vena cava removal site; however, the current status of the patient is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameECLIPSE 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 Key12121121
MDR Text Key260029198
Report Number2020394-2021-80536
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
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 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
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 Received06/09/2021
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: 07/06/2021 Patient Sequence Number: 1
Treatment
ALPRAZOLAM AND FLUNISOLIDE; HYDROCODONE, GABAPENTIN, LORATADINE, NAPROXEN; OMEPRAZOLE, TIZANIDINE, CITALOPRAM, MIRTAZAPINE
-
-