BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7602449 · Received June 14, 2018

    Report

    Report Number
    2210968-2018-73482
    Event Type
    Death
    Date Received
    June 14, 2018
    Report Date
    May 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENTS WERE REPORTED THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. 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. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CONFIRM THE REASON FOR THE OCCURRENCE OF SEPSIS THAT CAUSED THE DEATH OF 2 PATIENTS IN THE FIRST PERIOD. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS AND PATIENT DEATHS AS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: A NEW SIMPLIFIED TECHNIQUE OF ARTERIAL RECONSTRUCTION IN PEDIATRIC LIVING-DONOR LIVER TRANSPLANTATION: A COMPARISON WITH THE CLASSICAL TECHNIQUE. AUTHORS: ANA CRISTINA AOUN TANNURI, ROBERTA FIGUEIREDO MONTEIRO, MARIA MERCÊS SANTOS, HELENA THIE MIYATANI AND UENIS TANNURI. CITATION: JOURNAL OF PEDIATRIC SURGERY 49 (2014) 1518¿1521; HTTP://DX.DOI.ORG/10.1016/J.JPEDSURG.2014.02.084. THE AIM OF THIS RETROSPECTIVE COMPARATIVE STUDY WAS TO COMPARE THE INCIDENCE OF COMPLICATIONS AND OPERATIVE TIME BETWEEN ARTERIAL RECONSTRUCTIONS THAT WAS PERFORMED WITH AN OPERATING MICROSCOPE AND THE CLASSICAL TECHNIQUE OF 9-0 SEPARATE SUTURES AND ARTERIAL RECONSTRUCTION WHICH WAS PERFORMED USING A SIMPLER TECHNIQUE, WITH SURGICAL LOUPE AND CONTINUOUS 8-0 PROLENE SUTURES IN TWO PEDIATRIC LIVING DONOR LIVER TRANSPLANTATION (LDLT) SERIES. FROM JANUARY 2010 TO JUNE 2013, 82 LDLTS WERE PERFORMED, 38 IN THE FIRST PERIOD AND 44 IN THE SECOND PERIOD. DURING THE PROCEDURE, THE ORIFICES OF THE HEPATIC VEINS WERE CLOSED WITH CONTINUOUS 5-0 PROLENE SUTURES AND A WIDE LONGITUDINAL INCISION AT THE ANTERIOR WALL OF THE INFERIOR VENA CAVA WAS CREATED. THE LIVER GRAFT WAS POSITIONED NORMALLY, WITHOUT ANY ROTATION, AND A WIDE LONGITUDINAL ANASTOMOSIS WAS EASILY PERFORMED USING TWO LONG LINES OF CONTINUOUS 5-0 PROLENE SUTURES. IN PATIENTS IN THE FIRST PERIOD, THE ARTERIAL RECONSTRUCTION WAS PERFORMED USING AN OPERATING MICROSCOPE (MODEL OPMI 6-SFC, ZEISS, GERMANY), WITH INTERRUPTED 9-0 MONOFILAMENT POLYPROPYLENE SUTURES (ETHILON; ETHICON INC., SOMERVILLE, NJ, USA), ACCORDING TO THE CLASSICAL DESCRIPTIONS. IN PATIENTS IN THE SECOND PERIOD, THE ARTERIAL RECONSTRUCTION WAS PERFORMED WITH CONTINUOUS SUTURE USING 8-0 MONOFILAMENT POLYPROPYLENE SUTURES AND A 3.5× MAGNIFICATION LOUPE. THE OTHER 8-0 MONOFILAMENT POLYPROPYLENE SUTURE WAS THEN PLACED ON THE LEFT CORNER OF THE WALL OF BOTH THE RECIPIENT AND GRAFT ARTERIES; THEN THE SUTURE WAS CONTINUED TO THE RIGHT CORNER OF THE ANASTOMOSIS. THE ANASTOMOSIS BETWEEN THE GRAFT AND THE DONOR ARTERY WAS SIMILARLY PERFORMED WITH 8-0 RUNNING SUTURES. THE OCCURRENCE OF POSTOPERATIVE HEPATIC ARTERY THROMBOSIS, IN THE FIRST PERIOD, TWO CASES WERE OBSERVED. THE DIAGNOSIS WAS SUGGESTED ONLY BY THE ULTRASOUND EXAMINATION IN THE FIRST POSTOPERATIVE DAY. THESE PATIENTS UNDERWENT URGENT SURGICAL RE-EXPLORATION THAT CONFIRMED THE DIAGNOSIS, AND A RE-ANASTOMOSIS WAS PERFORMED, WITH THROMBOSIS RELAPSE. BOTH PATIENTS DIED OF SEPSIS: ONE PATIENT DIED BEFORE THE RE-TRANSPLANTATION, AND THE OTHER DIED AFTER THE PROCEDURE. IN CONCLUSION, HEPATIC ARTERY ANASTOMOSIS CAN BE SAFELY PERFORMED BY THE PEDIATRIC TRANSPLANT SURGEON WITH CONTINUOUS SUTURES USING A 3.5× MAGNIFYING LOUPE, WITH LOW COMPLICATION RATES. THIS TECHNIQUE IS SIMPLER, LESS TIME CONSUMING AND SIMPLIFIES THE COMPLEX PEDIATRIC LDLT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444746 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death