BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11530655 · Received March 19, 2021

    Report

    Report Number
    2210968-2021-02566
    Event Type
    Death
    Date Received
    March 19, 2021
    Date of Event
    June 1, 2011
    Report Date
    March 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). DATE SENT TO THE FDA: 03/19/2021. (B)(4) ¿ DEVICE NOT RETURNED. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS CITATION: LIVER TRANSPLANTATION. 2011 JUN; CONFERENCE: 2011 JOINT INTERNATIONAL CONGRESS OF ILTS, ELITA, AND LICAGE. VALENCIA SPAIN. CONFERENCE PUBLICATION: (VAR.PAGINGS). 17 (SUPPL. 1) :S240. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADVERSE EVENTS CASES SUBMITTED VIA 2210968-2021-02565. MORTALITY CASES SUBMITTED.

    Description of Event or Problem · 1

    TITLE: INCIDENCE OF HEPATIC ARTERY THROMBOSIS IN 522 CONSECUTIVE LIVING DONOR LIVER TRANSPLANTS. AUTHORS: MEHTA N.N; VARMA V; GOVINDASAMY M; KUMARAN V; MOHANKA R; RASTOGI A; NUNDY S; SOIN A. CITATION: LIVER TRANSPLANTATION. 2011 JUN; CONFERENCE: 2011 JOINT INTERNATIONAL CONGRESS OF ILTS, ELITA, AND LICAGE. VALENCIA SPAIN. CONFERENCE PUBLICATION: (VAR.PAGINGS). 17 (SUPPL. 1) :S240. THE AIM OF OUR PROSPECTIVE STUDY WAS TO DETERMINE INCIDENCE, TREATMENT AND CLINICAL OUTCOME OF HEPATIC ARTERY THROMBOSIS (HAT), IN PATIENTS UNDERGOING LIVING DONOR LIVING TRANSPLANTATION (LDLT). FIVE HUNDRED TWENTY-TWO CONSECUTIVE LDLT RECIPIENTS OPERATED BETWEEN JANUARY 2001 TILL MARCH 2010. DURING THE PROCEDURE, HEPATIC ARTERIAL ANASTOMOSES WAS PERFORMED WITH 7-0 PROLENE INTERRUPTED SUTURES (ETHICON) END TO END UNDER 2.5X SURGICAL LOUPE MAGNIFICATION. REPORTED COMPLICATIONS INCLUDED HAT (N=5 MALES, 3=FEMALES; MEAN AGE=44 YEARS, AGE RANGE=9 MONTHS ¿ 61 YEARS) IN WHICH 6 PATIENTS WERE RE-EXPLORED AND GRAFT ARTERIAL FLOW WAS SUCCESSFULLY RE-ESTABLISHED IN 5; REVASCULARIZATION WAS UNSUCCESSFUL (N=1) WHICH REQUIRED RE-TRANSPLANTATION; EXTENSIVE THROMBOSIS EXTENDING WITHIN THE GRAFT (N=1) WHICH THE PATIENT WAS TAKEN UP FOR RE-TRANSPLANTATION; POST-OPERATIVE MORTALITY INCLUDED SUCCUMBED TO SEPSIS (N=3) IN WHICH 2 PATIENTS IN THE POSTOPERATIVE PERIOD AND 1 DUE TO DELAYED BILIARY COMPLICATIONS. IN CONCLUSION, METICULOUS SURGICAL TECHNIQUE FOR HEPATIC ARTERY RECONSTRUCTION PREVENTS HAT. URGENT RE-VASCULARIZATION AND/OR RE-TRANSPLANTATION IS SUCCESSFUL AND SHOULD BE ATTEMPTED FOR HAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421118 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death