BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21437464 · Received February 21, 2025

    Report

    Report Number
    2024168-2025-01974
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    February 6, 2025
    Report Date
    April 7, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    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 DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. BASED ON THE REPORTED INFORMATION AND OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE 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 RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4: LOT # CORRECTED FROM 4110342 TO 4111441 D4: PRIMARY UDI NUMBER CORRECTED FROM (B)(4). H4: DEVICE MFG DATE CORRECTED FROM 11/3/2024 TO 11/14/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH TWO PROSTYLE DEVICES. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 14F SHEATH AND THE TAVI PROCEDURE WAS COMPLETED. COMPLETE HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. ADDITIONALLY, MANUAL COMPRESSION AND A Z-SUTURE WERE PERFORMED AS A PRECAUTION. 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
    1109807 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4111441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention