BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22878006 · Received August 22, 2025

    Report

    Report Number
    2024168-2025-08923
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE SEPARATION WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, LINK/SUTURE PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. D4: LOT NUMBER UPDATED FROM 4061741 TO 4092441. D4: CORRECTED EXPIRATION DATE FROM 5/31/2026 TO 8/31/2026. D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4) TO (B)(4). H4: CORRECTED DEVICE MFG DATE FROM 6/17/2024 TO 9/24/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED DURING REMOVAL OF THE PLUNGER. THE SUTURES OF TWO NEW PROSTYLE DEVICE WERE PRE-PLACED. THE SHEATH WAS UPSIZED TO 16F AND THE PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED VIA THE PRE-PLACED PROSTYLE SUTURES. 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
    2667711 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4092441 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention