BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1667850 · Received April 23, 2010

    Report

    Report Number
    2953144-2010-00695
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    March 27, 2010
    Report Date
    March 31, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE ISSUE: UNKNOWN. TIME OF DEVICE ISSUE: AFTER VESSEL CLOSURE. ADVERSE EVENT: PSEUDOANEURYSM, HEMODYNAMICALLY UNSTABLE, EXPIRED. IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED UNEVENTFUL ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY. AFTER AN INTERVENTIONAL CORONARY STENTING PROCEDURE, THE PT'S HOSPITALIZATION WAS EXTENDED FOR OBSERVATION. REPORTEDLY, DURING THE OBSERVATION, THE PT AMBULATED FOR FOUR DAYS WITH NO GROIN BLEEDING. ON THE FOURTH DAY OF OBSERVATION, THE PT FELT A "POP" AND THE ACCESS SITE BEGAN TO BLEED. AN ANGIOGRAM REVEALED THE PRESENCE OF A LARGE PSEUDOANEURYSM AT THE ARTERIOTOMY SITE. THE NEXT DAY, A NON-ABBOTT COVERED STENT WAS PERCUTANEOUS IMPLANTED AT THE ARTERY SITE TO STOP THE BLEEDING. WHILE IN THE INTENSIVE CARE UNIT, THE PT BECAME HEMODYNAMICALLY UNSTABLE AND EXPIRED ON (B) (6) 2010. THE PT WAS REPORTED TO BE FRAIL. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| R STENT: GORE 8X50 COVERED STENT