BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7603212 · Received June 14, 2018

    Report

    Report Number
    2210968-2018-73489
    Event Type
    Death
    Date Received
    June 14, 2018
    Report Date
    June 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE ? DOES THE SURGEON BELIEVE THAT PROLENE SUTURE CAUSED/ CONTRIBUTED TO THE PATIENT DEATH? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCT PROLENE USED IN THIS PROCEDURE? WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL AND ENGINEERING (TRANSLATION IS AVAILABLE)? CITATION: INTERACT CARDIOVASC THORAC SURG 2015;20:707¿11; DOI:10.1093/ICVTS/IVV065 - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: IS MINIMALLY INVASIVE MITRAL VALVE REPAIR WITH ARTIFICIAL CHORDS REPRODUCIBLE AND APPLICABLE IN ROUTINE SURGERY? AUTHOR(S): ARISTOTELIS PANOS, SYLVIO VLAD, FOTIOS MILAS AND PATRICK O. MYERS CITATION: INTERACT CARDIOVASC THORAC SURG 2015;20:707¿11; DOI:10.1093/ICVTS/IVV065. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO REVIEW THE EFFECTIVENESS AND REPRODUCIBILITY OF NEOCHORDAL REPAIR AS A ROUTINE APPROACH TO MINIMALLY INVASIVE MITRAL REPAIR, AND TO ASSESS THE STABILITY OF NEOCHORD IMPLANTATION USING THE FIGURE-OF-EIGHT SUTURE WITHOUT PLEDGETS IN THIS SETTING. BETWEEN 2008 AND 2013, 426 PATIENTS (AGE OF 55±18 YEARS) WHO UNDERWENT VIDEO-ASSISTED MITRAL VALVE REPAIR FOR DEGENERATIVE DISEASE OR HEALED ENDOCARDITIS OF THE POSTERIOR, ANTERIOR OR BOTH LEAFLETS. IN THE PROCEDURE, EPTFE (GORE) CV 4/0 WAS USED AS PREFORMED LOOPS WHICH WERE ANCHORED IN THE ADEQUATE PAPILLARY MUSCLE (PM) BY A FIGURE-OF-EIGHT SUTURE, WITHOUT TEFLON FELT OR PLEDGETS, AND THEN ATTACHED TO THE LEAFLET FREE MARGIN BY MEANS OF AN EPTFE CV 6/0 OR PROLENE 5/0 SUTURE. ONE PATIENT DIED WITHIN 30 DAYS OF MITRAL VALVE OPERATION. THIS PATIENT IS A (B)(6)-YEAR OLD PATIENT ON CHRONIC CORTICOTHERAPY DIED FROM MASSIVE HAEMORRHAGE FROM A TEAR ON THE SUTURE LINE OF THE LEFT ATRIUM. FIVE PATIENTS (1.1%) REQUIRED RE-EXPLORATION FOR BLEEDING (DECIDED ON THE BASIS OF >500 ML BLEEDING DURING THE FIRST HOUR DESPITE CORRECTION OF COAGULOPATHY) AND HAEMOSTASIS WAS ACHIEVED THROUGH THE SAME INCISION IN ALL OF THEM. NO VASCULAR OR WOUND COMPLICATIONS WERE OBSERVED. NO PATIENT REQUIRED REOPERATION DURING LATE FOLLOW-UP, AND THERE WERE NO LATE THROMBOEMBOLIC EVENTS. IN THE STUDY, THE SURGEONS DID NOT ENCOUNTER ANY DEHISCENCE OF THE MUSCLE DUE TO THE ABSENCE OF PLEDGETS. A FIGURE-OF-EIGHT EPTFE SUTURE PLACED IN A WIDE ANGLE AT THE ANATOMICAL CHORD POSITION (TIP OF THE PM) WITHOUT PLEDGETS FULFILS THE PHYSIOLOGICAL NEEDS AND TECHNICAL REQUIREMENTS FOR EXCELLENT LONG-TERM CLINICAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443217 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death