BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 19697035 · Received July 8, 2024

    Report

    Report Number
    2024168-2024-08033
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 14, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 OBSERVED AS A LINK SEPARATION. 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 UNEXPECTED MEDICAL INTERVENTION APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR SUTURE/LINK PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. D4 CORRECTION - LOT # UPDATED FROM 4021441 TO 4012342.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF A RIGHT FEMORAL VESSEL USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, A PROSTYLE CUFF MISS [SUTURE RETRIEVAL ISSUE] WAS NOTICED. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 14F, AND THE TAVI PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH 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
    134043 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4012342 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention