BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21775173 · Received April 4, 2025

    Report

    Report Number
    2024168-2025-03516
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 13, 2025
    Report Date
    May 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. 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 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. CORRECTIONS: D4 - LOT #: UPDATED FROM 4112742 TO 4121843. D4 - EXPIRATION DATE: UPDATED FROM 10/31/2026 TO 11/30/2026. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 11/27/2024 TO 12/18/2024.

    Additional Manufacturer Narrative · 0

    B5 - DESCRIBE EVENT OR PROBLEM: UPDATED AS ADDITIONAL INFORMATION WAS RECEIVED.

    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

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE SHEATH WAS UPSIZED TO 12F, THUS THE STENT GRAFTING PROCEDURE WAS COMPLETED USING THE 12F SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO AN INTERVENTIONAL STENT GRAFTING PROCEDURE. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH THE PROSTYLE DEVICE. THE SUTURE OF A NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE STENT GRAFTING PROCEDURE WAS COMPLETED USING THE SAME SHEATH. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURE. 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
    2333572 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4121843 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention