BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 5798168 · Received July 15, 2016

    Report

    Report Number
    2210968-2016-10503
    Event Type
    Injury
    Date Received
    July 15, 2016
    Report Date
    June 22, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATE SENT TO THE FDA: 07/15/2016. (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON 2-0 ETHIBOND SUTURES WERE RELATED TO ANY ADVERSE EVENTS IN THIS SERIES OF PATIENTS DESCRIBED IN THE ARTICLE? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? WHAT ARE PATIENT PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION? WERE THESE CASES PREVIOUSLY REPORTED? IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? IS THE LOT NUMBER AVAILABLE FOR ANY OF THE DEVICES USED?

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE WITH OR WITHOUT TRICUSPID VALVE SURGERY ON UNKNOWN DATE BETWEEN 01/1995 AND 12/2001 AND THE SUTURE WAS USED IN A PLEDGETED SUTURE TECHNIQUE. FOLLOWING THE PROCEDURE THE PATIENT POSSIBLY EXPERIENCED EXCESSIVE POSTOPERATIVE BLEEDING, WHICH NEEDED REOPERATION, MEDIASTINAL HEMATOMA, LEFT ATRIAL RUPTURE, PROSTHETIC VALVE ENDOCARDITIS/PVE, WHICH REQUIRED ANTIBIOTIC THERAPY OR REOPERATION, OR MAJOR PARAVALVULAR LEAK/PVL, WHICH WAS DETECTED BY TRANSTHORACIC ECHOCARDIOGRAPHY DURING THE POSTOPERATIVE PERIOD. THE PATIENT POSSIBLY EXPERIENCED ACUTE RENAL FAILURE, LOW CARDIAC OUTPUT SYNDROME, ARRHYTHMIAS, STROKE OR OPERATIVE EARLY MORTALITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452064 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention