BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT 5X10 COMPLEX FILL

    MDR report key: 788719 · Received December 17, 2004

    Report

    Report Number
    1058196-2004-00151
    Event Type
    Malfunction
    Date Received
    December 17, 2004
    Date of Event
    November 2, 2004
    Report Date
    December 17, 2004
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION FROM THE DATABASE INDICATED THE FOLLOWING: THE PATIENT IS A FEMALE. THE DATE OF THE PROCEDURE WAS 2004. THE PATIENT'S SYMPTOMS ON A MODIFIED RANKIN SCALE WERE 0 - NO SYMPTOMS AT ALL. THE PATIENT'S MEDICAL HISTORY INCLUDES: NO DIABETES, CURRENT SMOKING, NO HYPERTENSION OR USE OF ANTI-HYPERTENSIVE MEDICATIONS, AND PREVIOUS SUB ARACHNOID HEMORRHAGE OF OVER ONE (1) WEEK. THE PATIENT DID NOT HAVE AN INTRACRANIAL SHUNT INSERTION IN THE LAST 7 DAYS. THE NUMBER OF ANEURYSMS COILED IN THIS PATIENT WAS ONE (1). THE ANEURYSM WAS REPORTED TO BE FOUR (4) MM IN WIDTH AND FIVE (5) MM IN LENGTH. THE ANEURYSM HEIGHT WAS 5 MM. THE ANEURYSM'S NECK WAS REPORTED TO BE 4 MM DIAMETER AND A NECK/SAC RATIO OF ONE:ONE (1:1). THE ANEURYSM TYPE WAS REPORTED TO BE RUPTURED. THE DATE OF THE LAST RUPTURE WAS 2003. THE ANEURYSM WAS PREVIOUSLY TREATED - COILED. THE LOCATION WAS POSTERIOR CIRCULATION - BASILAR TERMINUS. THE SIDE WAS REPORTED TO BE OTHER. TWO (2) CORDIS TRUFILL DCS COMPLEX FILL COILS (A 5 X 10 MM AND 5 X 15 MM WERE USED) AS WELL AS ADDITIONAL NON-CORDIS NEUROVASCULAR COILS. THE ADDITIONAL COILS USED WERE DENDRON SAPPHIRE NEUROVASCULAR COILS (MICROTHERAPEUTICS/EV3). THE MICROCATHETER USED WAS IN ECHELON (MICROTHERAPEUTICS). THE GUIDEWIRE USED WAS MARKED- OTHER. THE GUIDING CATHETER WAS AN ENVOY XB (CORDIS NEUROVASCULAR). THE PROCEDURE WAS REPORTED TO HAVE TERMINATED BECAUSE OF A SATISFACTORY RESULT WITH THE LAST COIL. THE HOMOGENOUS COIL PACKING INTO THE ANEURYSM, HOMOGENEOUS AND COMPLETE NECK COVERAGE OF THE ANEURYSM, AND NECK COVERAGE WERE ALL REPORTED TO BE EXCELLENT. THE ESTIMATED ANGIOGRAPHIC OCCLUSION WAS REPORTED TO BE EXCELLENT AND WAS THE DESIRED CONCLUSION. AN ADVERSE EVENT (AE) WAS REPORTED TO HAVE OCCURRED IN 2004, WHICH WAS ONE (1) DAY AFTER THE INITIAL PROCEDURE. THE PATIENT'S MODIFIED RANKIN SCALE WAS 0-NO SYMPTOMS AT ALL. THE AE WAS REPORTED TO BE: COIL PROTRUSION INTO THE PARENT VESSEL. THE RELATIONSHIP TO THE TRUFILL DCS ORBIT COIL WAS REPORTED TO BE HIGHLY PROBABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCT IS INVOLVED IN THIS EVENT. IT IS UNKNOWN WHICH COIL PROTRUDED INTO THE PARENT ARTERY (REF MFR REPORT #1058196-2004-00150 & #1058196-2004-00151).

    Description of Event or Problem · 1

    COIL PROTRUSION INTO THE PARENT VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT 5X10 COMPLEX FILL CNV DCS ORBIT HCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR