FDA Adverse Event Injury Summary report: N

ECLIPSE

MDR report key: 2943720 · Received January 29, 2013

Report

Report Number
2943720
Event Type
Injury
Date Received
January 29, 2013
Date of Event
January 18, 2013
Report Date
January 29, 2013
Manufacturer
BARD PERIPHERAL VASCULAR, INC.
Product Code
DTK
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN, US

Narratives

Description of Event or Problem · 1

PATIENT WITH BARD ECLIPSE OPTIONAL IVC FILTER PLACED IN EARLY 2012 FOLLOWING POLYTRAUMA. PATIENT HAD A FAILED ATTEMPT AT IVC RETRIEVAL AT AN OUTSIDE INSTITUTION IN THE LATE FALL OF 2012. CT FROM OUTSIDE FACILITY DEMONSTRATED A FRACTURED FILTER LEG THAT WAS IMBEDDED WITHIN THE VERTEBRAL BODY. A 14F SHEATH WAS PLACED AND USING A LOOP SNARE TECHNIQUE, A GLIDEWIRE WAS USED TO ENCIRCLE THE FILTER SUCH THAT BOTH ENDS OF THE GLIDEWIRE WERE OUTSIDE OF THE SHEATH. USING MANIPULATION, THE HOOK WAS THEN BROUGHT INTO THE LUMEN AND A SNARE WAS USED TO SNARE THE HOOK AT THAT TIME. THE SHEATH WAS BROUGHT OVER THE FILTER AND THE FILTER WAS REMOVED IN ITS ENTIRETY. THE FILTER LEG THAT WAS FRACTURED PRIOR TO THE INITIATION OF PROCEDURE REMAINS IMBEDDED WITHIN THE VERTEBRAL BODY. POST REMOVAL CAVOGRAM DEMONSTRATES NORMAL IVC. THIS WAS PERFORMED IN SEVERAL OBLIQUITIES DEMONSTRATING THAT IF THERE IS ANY PORTION OF THIS FRAGMENT STILL REMAINING WITHIN THE IVC, IT IS A VERY MINIMAL PORTION. ATTEMPTS WERE MADE TO RETRIEVE THIS FRAGMENT BUT THE FILTER LEG WAS NOT ENGAGED BY THE SNARES OR CATHETERS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REMOVAL OF IVC FILTER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
39879 ECLIPSE VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. * #GFVJ2109

Patients

Seq Age Sex Outcome Treatment
1 * Other| R TRIEVE THE FRAGMENT OF THE FILTER LEG - THIS DID| NO OTHER THERAPIES| SNARES OR CATHETERS WERE UTILIZED TO ATTEMPT TO RE| NOT CONTRIBUTE TO THE EVENT