BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    MDR report key: 18005546 · Received October 25, 2023

    Report

    Report Number
    2024168-2023-11843
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    October 3, 2023
    Report Date
    January 11, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE FAILURE TO CYCLE WAS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE CAUSE OF THE REPORTED DIFFICULTIES AND THE SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT IS LIKELY THAT A DUAL CUFF MISS OCCURRED DUE TO AN INTERACTION WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT CONTRIBUTED TO THE REPORTED SUTURE RETRIEVAL ISSUE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4: LOT NUMBER UPDATED FROM 3032841 TO 2082141. D4: MANUFACTURING DATE AND H4: MANUFACTURING DATE UPDATED AS A RESULT.

    Additional Manufacturer Narrative · 0

    B3: DATE OF PROCEDURE ESTIMATED. 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

    IT WAS REPORTED THAT SUTURE PLACEMENT IN AN UNSPECIFIED ACCESS SITE WAS ATTEMPTED WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE MISFIRED [FALURE TO CYCLE]. THE SUTURE OF A NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED AND THE EVAR WAS COMPLETED. 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
    1151756 PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2082141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention