BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7630996 · Received June 22, 2018

    Report

    Report Number
    2210968-2018-73697
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS 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? CITATION: LIVER TRANSPLANTATION 23 751¿761 2017 AASLD. [(B)(4).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: RECONSTRUCTION OF ANOMALOUS PORTAL VENOUS BRANCHING IN RIGHT LOBE LIVING DONOR LIVER TRANSPLANTATION: MALATYA APPROACH AUTHOR(S): SEZAI YILMAZ, CUNEYT KAYAALP, BURAK ISIK, VEYSEL ERSAN, EMRAH OTAN, SAMI AKBULUT, ABUZER DIRICAN, RAMAZAN KUTLU, AYSEGUL SAGIR KAHRAMAN, CENGIZ ARA, MEHMET YILMAZ, BULENT UNAL, CEMALETTIN AYDIN, TURGUT PISKIN, DINCER OZGOR, MUSTAFA ATES, FATIH OZDEMIR, VOLKAN INCE, CEMALETTIN KOC, ADIL BASKIRAN, SAIT MURAT DOGAN, BORA BARUT, FATIH SUMER, SERDAR KARAKAS, KORAY KUTLUTURK, SAIM YOLOGLU, AND HARIKA GOZUKARA. CITATION: LIVER TRANSPLANTATION 23 751¿761 2017 AASLD. THE GOAL OF THIS STUDY WAS TO DESCRIBE THE SURGICAL TECHNIQUE OF MALATYA APPROACH IN CASE OF ANOMALOUS PORTAL VEIN BRANCHING (APVB) DURING RIGHT LOBE LIVING DONOR LIVER TRANSPLANTATION (LDLT). FROM MAR 2002 UNTIL JUN 2016, 126 PATIENTS HAD APVB ON RIGHT LOBE GRAFTS AND WERE DIVIDED INTO 2 GROUPS FOR THE SURGICAL TECHNIQUE: MALATYA APPROACH GROUP (N=91) AND OTHER TECHNIQUE GROUP (N=35). IN MALATYA APPROACH GROUP, THE TWO PORTAL VENOUS OPENING CLOSEST EDGE WERE JOINED WITH 7/0 PROLENE SUTURES. THE AUTOLOGOUS SAPHENOUS VEIN WAS SUTURED AROUND THE JOINED VESSEL LIKE A CIRCUMFERENTIAL FENCE USING 7/0 PROLENE SUTURES. OVERALL IN MALATYA APPROACH GROUP, COMPLICATIONS INCLUDED PORTAL VEIN THROMBOSIS (N=3), HEPATIC ARTERY THROMBOSIS (N=1), AND BILE PERITONITIS (N=4). RELAPAROTOMIES WERE PERFORMED FOR THESE COMPLICATION (EXCEPT FOR 2 PATIENTS WITH PORTAL VEIN THROMOBOSIS) WITH ADDITIONAL REVASCULARIZATION ON THE PATIENT WITH HEPATIC ARTERY THROMOBOSIS. NO MAJOR DONOR COMPLICATIONS REQUIRING REOPERATION OR ENDOSCOPIC OR RADIOLOGIC INTERVENTION OCCURRED IN ANY OF THE 126 LIVING DONORS WITH APVB. THE RESULTS REFLECT REALISTIC OUTCOMES IN TERMS OF PVT AND MORTALITY CONFIRMING THAT THE USE OF THIS TECHNIQUE AND ITS VARIATIONS CAN BE THE STANDARD PROCEDURE FOR RECONSTRUCTION OF RL GRAFTS WITH DOUBLE PORTAL VEIN ORIFICES. MALATYA APPROACH WITH ITS MODIFICATIONS IS APPLICABLE TO ALL PATIENTS WITH APVB IN RIGHT LOBE LDLT, EXCEPT FOR DONORS WITH RIGHT ANTERIOR PORTAL VEIN ORIGINATING FROM THE UMBILICAL PORTION OF THE LEFT PORTAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474089 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention