BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PERCLOSE

    MDR report key: 19160498 · Received April 22, 2024

    Report

    Report Number
    2024168-2024-04992
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 22, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. LOT HISTORY RECORD (LHR) REVIEW COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS NOT PERFORMED BECAUSE A SPECIFIC FAILURE MODE FOR THIS COMPLAINT WAS NOT PROVIDED. A QUERY OF THE COMPLAINT HANDLING DATABASE COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. WITHOUT THE DEVICE RETURNED FOR ANALYSIS AND SPECIFIED FAILURE MODE A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ATTACHMENT: USER MEDWATCH #5152967.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "EVENT DESCRIPTION: AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, AFTER SUCCESSFUL IMPLANT OF A SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, A PERCLOSE FAILURE OCCURRED AND AN EXTRAVASATION WAS NOTED BY ANGIO. AFTER PTA AND COVERED STENT EXTRAVASATION, THE EVENT RESOLVED. PATIENT WAS TRANSFERRED IN STABLE CONDITION FOR POST MANAGEMENT CARE. THERE WAS NO ALLEGATION OF ANY EDWARDS DEVICE THAT CAUSED THE EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942588 UNK PERCLOSE VESSEL CLOSURE SUTURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention