BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22793166 · Received August 13, 2025

    Report

    Report Number
    2024168-2025-08371
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 22, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS 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 DIFFICULTY 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. 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. CORRECTIONS: D4 - LOT #: UPDATED FROM 5061241 TO 5032641. D4 - EXPIRATION DATE: UPDATED FROM 5/31/2027 TO 2/28/2027. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 6/1/2025 TO 3/26/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A CALCIFIED LEFT COMMON FEMORAL ARTERY USING FOUR PROSTYLE DEVICES RELATED TO AN INTERVENTIONAL ENDOVASCULAR ANEURYSM REPAIR PROCEDURE WITH A 6FR SHEATH. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH ALL FOUR DEVICES. A CUT DOWN SURGERY WAS DONE TO ACHIEVE HEMOSTASIS CAUSING A DELAY IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813848 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 5032641 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention