BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT 3X4 MINI COMPLEX FILL

    MDR report key: 725441 · Received May 1, 2006

    Report

    Report Number
    1058196-2006-00084
    Event Type
    Injury
    Date Received
    May 1, 2006
    Date of Event
    March 11, 2005
    Report Date
    April 28, 2006
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORT WE RECEIVED VIA THE COMPLEX STUDY INDICATED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY PLACING THE FIRST COIL IN A 4X3X3MM LARGE ACOM ANEURYSM WHICH HAD A BROAD BASE OF APPROXIMATELY 2.5MM. ADDITIONAL INFORMATION RECEIVED ON APRIL 21, 2005 INDICATED THAT DURING INSERTION OF THIS FIRST COIL USING A REMODELING TECHNIQUE, THERE WAS A PERFORATION OF THE ANEURYSM. A MODERATE RE-BLEEDING OCCURRED, BUT WAS SEALED BY USING A BALLOON (FOR NECK PROTECTION) AND AN ADDITIONAL COIL. THE PATIENT SUFFERED TRANSIENT LEFT-SIDED HEMIPARESIS BUT HAS RECOVERED. THE PHYSICIAN STATED THAT THE USE OF THE REMODELING TECHNIQUE LIKELY INFLUENCED THE EVENT AS IT REDUCES THE FLEXIBILITY OF THE MICROCATHETER, INHIBITING ITS MOVEMENT. IT WAS STATED THAT THE SIZE OF THE COIL WAS COMPLETELY ACCURATE FOR THE ANEURYSM BEING COILED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS FILE HAS BEEN DEEMED REPORTABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT 3X4 MINI COMPLEX FILL CNV DCS ORBIT HCG CORDIS NEUROVASCULAR, INC. NA 13049299

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other