BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18124262 · Received November 13, 2023

    Report

    Report Number
    2024168-2023-12583
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    October 11, 2023
    Report Date
    March 18, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED ¿DEVICE FAILED TO DEPLOY PROPERLY¿ WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4, LOT# WAS UPDATED FROM "3070742" TO "3070841".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE USING A PROSTYLE DEVICE RELATIVE TO AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. REPORTEDLY, THE PROSTYLE DEVICE FAILED TO DEPLOY PROPERLY. A NEW PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES,¿DESCRIBE THE EVENT OR PROBLEM: FAILURE OF PRODUCT TO DEPLOY PROPERLY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : AAA ENDO WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ;" NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042401 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3070841 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention