BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1666487 · Received April 22, 2010

    Report

    Report Number
    2953144-2010-00685
    Event Type
    Injury
    Date Received
    April 22, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 29, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). DEVICE #2: PART #12322-02, LOT #86012-6H INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. DEVICE #3: PART #12322-02, LOT# UNK INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. (B) (4) - OFF LABEL USE; PATIENT SELECTION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE #1 ISSUE: NONE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. TIME OF ADVERSE EVENT: DURING VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (LSFA) AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "WHILE ADVANCING THE KNOT ALL THE WAY TO THE END, THEY WEREN'T ABLE TO CLOSE THE (L)SFA." A SECOND PROSTAR XL DEVICE WAS ATTEMPTED, BUT AFTER ADVANCING THE KNOT TO THE ARTERIAL SURFACE, THE VESSEL COULD NOT BE "CLOSED." A CUT-DOWN WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED SURGICALLY. IN ADDITION, IT WAS REPORTED THAT ARTERIOTOMY CLOSURE WAS ATTEMPTED OF A HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). DURING DEVICE POSITIONING IN THE VESSEL, ARTERIAL LUMINAL MARKING COULD NOT BE ACHIEVED AS INDICATED BY NO "PULSATING BLOOD FROM THE MARKER LUMEN." THE DEVICE WAS REMOVED, A CUT-DOWN WAS PERFORMED, AND HEMOSTASIS WAS ACHIEVED SURGICALLY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR - REDWOOD CITY NA 87007-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART #12322-02, LOT #86012-6H| PART #12322-02, LOT #UNK| DEVICE #2, PROSTAR| DEVICE #3, PROSTAR