BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7613038 · Received June 19, 2018

    Report

    Report Number
    2210968-2018-73546
    Event Type
    Death
    Date Received
    June 19, 2018
    Report Date
    May 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS AND PATIENT DEATH AS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ASIAN JOURNAL OF SURGERY (2015) 38, 229-231; DOI: HTTP://DX.DOI.ORG/10.1016/J.ASJSUR.2015.07.006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MODIFIED BACK WALL FIRST ARTERY ANASTOMOSIS TECHNIQUE IN LIVING DONOR LIVER TRANSPLANTATION" AUTHOR(S): SACIT COBAN, FAHRETTIN YILDIZ CITATION: ASIAN JOURNAL OF SURGERY (2015) 38, 229-231; DOI: HTTP://DX.DOI.ORG/10.1016/J.ASJSUR.2015.07.006. THE STUDY AIMED TO PRESENT THE MODIFIED BACK WALL ARTERY ANASTOMOSIS TECHNIQUE IN LIVING-DONOR LIVER TRANSPLANTATION IN CASES OF INSUFFICIENT LENGTH OF THE GRAFT OR RECIPIENT ARTERY WHERE THE MICROCLAMP CANNOT BE ROTATED. BETWEEN 2009 AND 2014, 29 PATIENTS (N=18 MALE AND N=11 FEMALE; MEAN AGE OF 50.1 YEARS [RANGED FROM 6 TO 65 YEARS]) UNDERWENT LIVING-DONOR LIVER TRANSPLANTATION USING CONVENTIONAL TWIST TECHNIQUE FOR SUFFICIENT LENGTH OF VESSEL AND MODIFIED TECHNIQUE FOR SHORT VESSEL. IN FOUR PATIENTS, THE GRAFT ARTERY WAS PERFORMED, BUT WAS OF THESE PATIENT WAS OPERATED BEFORE USING A MODIFIED TECHNIQUE SO ARTERY WAS RECONSTRUCTED WITH THE CONVENTIONAL TECHNIQUE. IN ALL PATIENTS, THE ARTERIAL RECONSTRUCTION WAS PERFORMED WITH INTERRUPTED SUTURES USING 8-0 PROLENE SUTURES. ONE PATIENT WHO WAS OPERATED USING CONVENTIONAL TECHNIQUE DEVELOPED HEPATIC ARTERY THROMBOSIS AND DIED DUE TO SEPSIS. THERE WAS NO CASE OF HAT IN PATIENTS THAT WERE RECONSTRUCTED WITH THE MODIFIED TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458818 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death