BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22062673 · Received May 21, 2025

    Report

    Report Number
    2024168-2025-05293
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 28, 2025
    Report Date
    July 2, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. THE ADDITIONAL PROSTYLE DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DEVICE BROKE COULD NOT BE CONFIRMED DUE TO ALL COMPONENTS WERE NOT RETURNED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED AND RETURN DEVICE ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED BREAK COULD NOT BE DETERMINED DUE TO ALL COMPONENTS WERE NOT RETURNED. THE SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. CORRECTIONS: D4 - LOT #: UPDATED FROM 5040342 TO 5040341. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 18F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) INTERVENTIONAL PROCEDURE. REPORTEDLY, TWO PROSTYLE DEVICES "BROKE". THE SUTURES OF TWO NEW PERCLOSE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE TAVR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PERCLOSE SUTURES. 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
    51131 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 5040341 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention