BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7628814 · Received June 22, 2018

    Report

    Report Number
    2210968-2018-73674
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    May 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 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 ETHICON PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: LIVER TRANSPLANTATION. 2015; 21(1). DOI: 10.1002/LT.24008. [(B)(4).PDF].

    Description of Event or Problem · 1

    TITLE : SUCCESSFUL LIVING DONOR LIVER TRANSPLANTATION WITH CAVOPORTAL HEMITRANSPOSITION IN DIFFUSE PORTOMESENTERIC THROMBOSIS. AUTHORS: MANISH SRIVASTAVA, M.B.B.S., M.S., D.N.B.; VINAY KUMARAN, M.B.B.S., M.S., M.CH.; SAMIRAN NUNDY, M.A., M.CHIR., F.R.C.S., F.R.C.P.; NAIMISH MEHTA, M.B.B.S., M.S., F.A.C.R.S.I., F.E.B.S. CITATION: LIVER TRANSPLANTATION. 2015; 21(1). DOI: 10.1002/LT.24008. THE AUTHORS DESCRIBED A SUCCESSFUL CASE OF LIVING DONOR LIVER TRANSPLANTATION (LDLT) WITH CAVOPORTAL HEMITRANSPOSITION (CPHT) PERFORMED IN A PATIENT WHO HAD END-STAGE LIVER DISEASE FROM CRYPTOGENIC CIRRHOSIS WITH DIFFUSE PORTOMESENTERIC THROMBOSIS (YERDEL GRADE 4). A (B)(6) MAN WAS PRESENTED WITH ABDOMINAL DISTENSION, JAUNDICE, 2 BOUTS OF HEMATEMESIS, AND 1 EPISODE OF HEPATIC ENCEPHALOPATHY. FURTHER INVESTIGATIONS REVEALED CRYPTOGENIC CIRRHOSIS LEADING TO END-STAGE LIVER DISEASE WITH DIFFUSE PORTOMESENTERIC THROMBOSIS (YERDEL GRADE 4). DURING THE SURGICAL PROCEDURE, THE HEPATIC VENOUS RECONSTRUCTION USED AN ANASTOMOSIS OF THE GRAFT RIGHT HEPATIC VEIN TO THE RECIPIENT RIGHT HEPATIC VEIN WITH THE INFERIOR VENA CAVA (IVC) WITH A PROLENE 4-0 CONTINUOUS SUTURE AND THE MHV CONDUIT TO THE IVC WITH A PROLENE 5-0 CONTINUOUS SUTURE. THE LOWER END OF THE IVC WAS PARTIALLY CLOSED WITH PROLENE 5-0 SUTURE TO REDUCE THE CALIBER OF THE IVC TO MATCH THE GRAFT PV CALIBER. THE END-TO-END CAVOPORTAL ANASTOMOSIS WAS FASHIONED BETWEEN THE LOWER END OF THE RECIPIENT IVC AND THE GRAFT PC WITH A PROLENE 5-0 CONTINUOUS SUTURE AND THE USE OF A GROWTH FACTOR TO ADJUST FOR THE SIZE DISCREPANCY BETWEEN THE VEINS. THE HEPATIC ARTERY (HA) ANASTOMOSIS USING PROLENE 7-0 INTERRUPTED SUTURES AND THE BILE DUCT ANASTOMOSIS (ROUX-EN-Y HEPATICOJEJUNOSTOMY, POLYDIOXANONE INTERRUPTED SUTURES) WERE THEN PERFORMED. REPORTED COMPLICATION INCLUDED PANCYTOPENIA ON POST-OPERATIVE DAY 18 WHICH REQUIRED RE-ADMISSION AND ADMINISTRATION OF 2 UNITS OF BLOOD AND WAS DISCHARGED. IT WAS CONCLUDED THAT LDLT WITH CPHT IS FEASIBLE, SAFE, AND EFFECTIVE IN SELECT RECIPIENTS WHO HAVE DIFFUSE THROMBOSIS OF THE PORTOMESENTERIC SYSTEM. FINAL RECIPIENT SELECTION DEPENDS ON THE EXPERIENCE OF THE LIVER TRANSPLANT SURGEON AND TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471763 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention