BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 16008288 · Received December 19, 2022

    Report

    Report Number
    2024168-2022-12831
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    November 30, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PROSTYLE DEVICE WITH REPORTED ISSUE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED CUFF MISS COULD NOT BE TESTED DUE TO DEVICE COMPONENTS NOT BEING RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D4: LOT NUMBER CHANGED FROM 2061341 TO 2072841.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING TWO PROSTYLE DEVICES DEVICE RELATIVE TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE FOOT OF THE FIRST PROSTYLE DEVICE WAS STUCK OPEN EVEN WHEN THE LEVER WAS OPENED AND CLOSED. THE DEVICE WAS REMOVED WITH FORCE. NO VESSEL OR TISSUE DAMAGE WAS NOTED. ANOTHER PROSTYLE DEVICE WAS DEPLOYED; HOWEVER, A CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED. TWO ADDITIONAL PROSTYLES WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097305 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2072841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention