BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1747578 · Received July 1, 2010

    Report

    Report Number
    2953144-2010-01235
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 8, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4): DEVICE #2 PART #12322-01, LOT #87012-6H INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE 1# ISSUE: SUTURE BREAK. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING A ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE, TWO PROSTAR XL DEVICE WERE USED, ONE IN THE LEFT COMMON FEMORAL ARTERY AND ONE IN THE RIGHT COMMON FEMORAL ARTERY. THE LEFT COMMON FEMORAL ARTERY WAS CLOSED SUCCESSFULLY. HOWEVER, WHEN ADVANCING THE KNOT DOWN TO THE ARTERY WALL, A SUTURE BREAK OCCURRED IN THE RIGHT COMMON FEMORAL ARTERY. THE DEVICE WAS REMOVED AND A SECOND PROSTAR XL WAS USED WITH THE SAME RESULTS. A CUT-DOWN PROCEDURE WAS PERFORMED AT THE RIGHT COMMON FEMORAL ARTERY ARTERIOTOMY SITE AND THE VESSEL WAS SURGICALLY SUTURED ACHIEVING HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR - REDWOOD CITY NA 83032-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #2, PROSTAR, PART #12322-01, LOT #87012-6H