BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 7652171 · Received June 29, 2018

    Report

    Report Number
    2210968-2018-73951
    Event Type
    Injury
    Date Received
    June 29, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 06/29/2018. 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 DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ANN TRANSPLANT. 2013; 18: 223-230. DOI: 10.12659/AOT.883914. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : INCIDENCE, RISK FACTORS AND MANAGEMENT OF INCISIONALHERNIA IN A HIGH VOLUME LIVER TRANSPLANT CENTER." AUTHOR : PANAGIOTIS FIKATASABCEF, WENTZEL SCHOENINGAB, JI-EUN LEEBC, SASCHA SANTOSH CHOPRABF, DANIEL SEEHOFERAB, OLAF GUCKELBERGERAB, GERO PUHLAB, PETER NEUHAUSAB, SVEN C. SCHMIDT. CITATION: ANN TRANSPLANT. 2013; 18: 223-230. DOI: 10.12659/AOT.883914. INCISIONAL HERNIA AFTER LIVER TRANSPLANTATION IS A COMMON COMPLICATION WITH AN INCIDENCE BETWEEN 5% AND 34%. THIS PROSPECTIVE STUDY ANALYZED RISK FACTORS, SURGICAL MANAGEMENT AND LONG-TERM RESULTS AFTER HERNIA REPAIR. BETWEEN FEBRUARY 2002 AND AUGUST 2009, A TOTAL OF 810 ORTHOTOPIC LIVER TRANSPLANTATIONS (OLTX) WERE PERFORMED IN THE CENTER. DURING THIS PERIOD, 77 PATIENTS REQUIRED THE REPAIR OF INCISIONAL HERNIAS (52 MALE AND 25 FEMALE PATIENTS; AGE: 54.2; BMI: 26 ± 4.3). THE AUTHORS COMPARED THE GROUP OF PATIENTS WITH INCISIONAL HERNIA REPAIR TO PATIENTS WITHOUT HERNIA REPAIR (N=733; 467 MALE AND 266 FEMALE PATIENTS; AGE: 49.9; BMI: 24.9 ± 4.6). STANDARD ACCESS FOR LIVER TRANSPLANTATION WAS A TRANSVERSE BILATERAL SUBCOSTAL LAPAROTOMY WITH A CRANIAL MIDLINE EXTENSION (MERCEDES INCISION). CLOSURE OF THE ABDOMEN WAS PERFORMED WITH A SLOWLY ABSORBABLE TWO-LAYER RUNNING PDS 1-0 SLING SUTURE. THE REPAIR OF INCISIONAL HERNIAS WAS PERFORMED BY A RE-APPROXIMATION OF THE FASCIA WITH INTERRUPTED NON-ABSORBABLE SUTURES FOR DEFECTS SMALLER THAN 2.5 CM OR BY A REINFORCEMENT OF THE FASCIA WITH THE IMPLANTATION OF VYPRO II OR ULTRAPRO ABSORBABLE MESH FOR LARGER HERNIAS. THE AUTHORS USED THE SUBLAY TECHNIQUE WITH AN IMPLANTATION OF THE MESH BETWEEN THE CLOSED POSTERIOR FASCIA AND THE MUSCLE IN THE MAJORITY OF PATIENTS. THE OVERLAP OF THE MESH EXTENDED APPROXIMATELY 5 CM BEYOND THE DEFECT. THE ONLAY TECHNIQUE WITH IMPLANTATION OF THE MESH ON THE ANTERIOR FASCIA WAS USED IN SOME PATIENTS WITH EXTENSIVE ABDOMINAL ADHESIONS. THE MESH WAS FIXED WITH PROLENE 2-0 SUTURES ON THE FASCIA IN BOTH TECHNIQUES. THE INTRAPERITONEAL ONLAY PLACEMENT OF A DUAL-LAYER COMPOSITE MESH WAS USED IN 13 PATIENTS ACCORDING TO THE SURGEON¿S PREFERENCE. THE MESH WAS FIXED WITH PROLENE 2-0 SUTURES EVERY 3 CM AROUND THE BORDER. IN BOTH GROUPS, REPORTED COMPLICATIONS INCLUDED ACUTE GRAFT REJECTIONS (N-196) WHICH REQUIRED 1500 MG OF CORTICOSTEROIDS OVER 3 DAYS. IN THE INCISIONAL HERNIA GROUP, REPORTED COMPLICATIONS INCLUDED RECURRENCE OF HERNIA (N-2; 15.4%) IN THE SUTURE REPAIR GROUP AND RECURRENCE OF HERNIA (N-10; 15.6%) IN THE MESH TECHNIQUE GROUP. IN THE STUDY, AN OLDER AGE, BODY MASS INDEX, AND POST-TRANSPLANT RE-LAPAROTOMY WERE MAJOR INDEPENDENT RISK FACTORS FOR THE DEVELOPMENT OF INCISIONAL HERNIAS AFTER LIVER TRANSPLANTATION. MESH IMPLANTATION IS STRONGLY SUGGESTED IN THE MAJORITY OF PATIENTS. THE EARLY RESULTS OF LAPAROSCOPIC INCISIONAL HERNIA AFTER LIVER TRANSPLANTATION ARE PROMISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493641 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention