BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20643599 · Received November 8, 2024

    Report

    Report Number
    2024168-2024-13198
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    October 10, 2024
    Report Date
    December 17, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IT IS LIKELY THAT 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 CORRECTION: LOT # UPDATED FROM 4062342 TO 4071041.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED EUMIR REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE SHEATH WAS UPSIZED TO 18F IN THE RIGHT COMMON FEMORAL ARTERY. THE PROCEDURE SUCCESSFULLY ENDED WITH THE CONTRALATERAL 8F ACCESS, WHERE ONE PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, FOUR PROSTYLE DEVICES FAILED DUE TO A CUFF MISS [SUTURE RETRIEVAL ISSUE]. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 18F AND THE EVAR PROCEDURE WAS COMPLETED. POST PROCEDURE, THE TWO SUTURES CAME OUT OF THE ARTERY DURING KNOT ADVANCEMENT. HEMOSTASIS WAS ACHIEVED VIA SURGERY. THE PROCEDURE SUCCESSFULLY ENDED WITH THE CONTRALATERAL 8F ACCESS, WHERE ONE PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED 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
    2111725 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4071041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention