BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7853032 · Received September 6, 2018

    Report

    Report Number
    2210968-2018-75688
    Event Type
    Injury
    Date Received
    September 6, 2018
    Report Date
    August 17, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: J CARD SURG 2014; 29: 476¿477. DOI: 10.1111/JOCS.12346. (B)(4).

    Description of Event or Problem · 1

    TITLE: LIVER LACERATION FROM A DIAPHRAGMATIC SUTURE IN MINITHORACOTOMY MITRAL VALVE REPAIR AUTHORS: PETER W. HASHIM, B.A., AND SABET W. HASHIM, M.D. CITATION: J CARD SURG 2014; 29: 476¿477. DOI: 10.1111/JOCS.12346. THE AUTHORS REPORTED THE MANAGEMENT OF A COMPLICATION OF THE DIAPHRAGMATIC SUTURE, WHICH RESULTED IN LIVER LACERATION, AND ITS SUCCESSFUL TREATMENT WITH ARTERIAL EMBOLIZATION. A (B)(6) MALE PATIENT PRESENTED WITH SEVERE MITRAL REGURGITATION TWO YEARS STATUS POST AN ACUTE MYOCARDIAL INFARCTION TREATED WITH MULTIPLE DRUG-ELUTING STENTS. THE PATIENT UNDERWENT MINIMALLY INVASIVE MITRAL VALVE REPAIR (MVR) THROUGH A RIGHT ANTERIOR THORACOTOMY WITH FEMORAL ARTERY AND VENOUS CANNULATION. ONE DIAPHRAGMATIC SUTURE AND THREE PERICARDIAL SUTURES, ALL ETHIBOND EXCEL (ETHICON) WERE PLACED FOR RETRACTION. FOLLOWING CARDIOPULMONARY BYPASS, THERE WAS TRACE MITRAL REGURGITATION AND NO SYSTOLIC ANTERIOR MOTION. THE CHEST WAS DRAINED WITH ONE PLEURAL CHEST TUBE AND THEN CLOSED. POSTOPERATIVELY, THE PATIENT BECAME HYPOTENSIVE, TACHYCARDIC, AND ACIDOTIC OVER A PERIOD OF SEVEN HOURS. FURTHER EXAMINATION REVEALED INTRAABDOMINAL BLEEDING AND A LARGE HEMOPERITONEUM DUE TO LACERATION OF THE LIVER WHICH REQUIRED BLOOD TRANSFUSION, SELECTIVE CANNULATION OF THE VESSELS, AND EMBOLIZATION OF THE INDIVIDUAL VESSELS. THE PATIENT¿S HEMODYNAMIC STATUS IMMEDIATELY STABILIZED. THE AUTHORS REPORTED THAT IT WAS NOT CLEAR WHETHER THE INJURY TO THE DOME OF THE LIVER WAS CAUSED BY THE NEEDLE PUNCTURE OR BY THE SUTURE THREAD ACCIDENTALLY TRAVELING THROUGH THE LIVER TOWARDS THE SKIN. AS BOTH INJURIES ARE POSSIBLE, THE AUTHORS BELIEVED THAT ATTENTION SHOULD BE DIRECTED NOT ONLY TOWARDS THE PLACEMENT OF THE SUTURE BUT ALSO TOWARDS GUIDING ITS EXIT TO THE SKIN; THE THREAD MUST REMAIN INTRATHORACIC AT ALL TIMES. THIS REPORT PROVIDES A DETAILED ACCOUNT OF SUCH A COMPLICATION OCCURRING SECONDARY TO A DIAPHRAGMATIC SUTURE DURING A MINITHORACOTOMY APPROACH FOR MVR. TREATMENT WITH HEPATIC ARTERY EMBOLIZATION PROVIDED AN EFFECTIVE THERAPY FOR THIS COMPLICATION. THE AUTHORS BELIEVED THAT RETRACTION WITH A DIAPHRAGMATIC SUTURE SHOULD BE SELECTIVE AND EXECUTED WITH CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691653 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention