BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1695084 · Received May 18, 2010

    Report

    Report Number
    2024168-2010-01008
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 29, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THERE WAS NO REPORTED VOYAGER NC DILATATION CATHETER PRODUCT DEFICIENCY. THE REPORTED PERFORATION AND DEATH ARE KNOWN ADVERSE EVENTS LISTED IN THE VOYAGER NC INSTRUCTIONS FOR USE (IFU). PERFORATION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: REQUIRED INTERVENTION/SUBSEQUENT DEATH. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING DILATATION OF THE CIRCUMFLEX VESSEL WITH A VOYAGER NC WHICH WAS PRESSURIZED TO 12 ATM, A PERFORATION OCCURRED. THE GRAFTMASTER STENT WAS BEING USED TO TREAT THE PERFORATION; HOWEVER, IT WAS UNABLE TO CROSS. THEREFORE, COILING OF THE CORONARY ARTERY WAS PERFORMED AND THE PT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PT DIED SIX DAYS LATER ((B) (6) 2010). NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R