BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX

    MDR report key: 6957960 · Received October 18, 2017

    Report

    Report Number
    9615742-2017-05559
    Event Type
    Injury
    Date Received
    October 18, 2017
    Report Date
    October 18, 2017
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC COMPLAINT REPORT: (B)(4), ARTICLE: HERNIA (2017) 21 (SUPPL 2):S208¿S263 IPOM COMBINED WITH ANTERIOR COMPONENT SEPARATION TECHNIQUE IN GIANT INCISIONAL VENTRAL HERNIA REPAIRS SHUPYK NATIONAL MEDICAL ACADEMY OF POST-GRADUATE EDUCATION, KYIV, UKRAINE AUTHORS: Y. P. FELESHTYNSKY, V. V. SMISHCHUK, V. F. VATAMANIUK.

    Description of Event or Problem · 1

    HERNIA (2017) 21 (SUPPL 2):S208¿S263 ARTICLE: IPOM COMBINED WITH ANTERIOR COMPONENT SEPARATION TECHNIQUE IN GIANT INCISIONAL VENTRAL HERNIA REPAIRS Y. P. FELESHTYNSKY, V. V. SMISHCHUK, V. F. VATAMANIUK SHUPYK NATIONAL MEDICAL ACADEMY OF POST-GRADUATE EDUCATION, KYIV, UKRAINE BACKGROUND: CLASSICAL METHODS OF ALLOHERNIOPLASTY FOR GIANT INCISIONAL VENTRAL HERNIA (IVH) OFTEN GIVE RISE TO A REDUCTION IN VOLUME OF THE ABDOMEN AND INCREASED INTRA-ABDOMINAL PRESSURE (IAP), WHICH RESULTS IN ABDOMINAL COMPARTMENT SYNDROME (ACS) (2.4¿6.4%) AND MORTALITY (0.9¿1.2%). THIS REQUIRES A SPECIAL TECHNIQUE FOR GIANT ABDOMINAL WALL DEFECT REPAIR WITHOUT INCREASED INTRA-ABDOMINAL PRESSURE. METHODS: 164 PATIENTS AGED 30¿75 WERE OPERATED FOR GIANT IVH. DEPENDING ON THE WAY OF ALLOPLASTY, IVH PATIENTS WERE DIVIDED INTO TWO GROUPS. IN GROUP I (82 PATIENTS), THERE WAS USED ACST, THE RECTUS ABDOMINIS MUSCLES SUTURING COMBINED WITH ¿¿ONLAY¿¿ TECHNIQUE. IN GROUP II (82 PATIENTS), ACST WAS COMBINED WITH IPOM, DOSED APPOSING OF THE RECTUS ABDOMINIS MUSCLES WAS PERFORMED UNDER IAP CONTROL. POLYPROPYLENE MESH IMPLANTS WERE USED IN GROUP I. IN PATIENTS FROM GROUP II THERE WERE USED COMPOSITE MESH IMPLANTS (PROSEED, PHYSIOMESH, PARIETEX COMPOSITE). RESULTS: 24 H AFTER THE SURGERY THE MEAN IAP WAS 15.1 ± 1.2 IN 5 (6.1 ± 2.6)% PATIENTS FROM GROUP I AND IT WAS ACCOMPANIED WITH ACS, GRADE I. AT THE SAME TIME POINT, THE MEAN IAP IN GROUP II WAS 6.3 ± 1.2 WITH NO ACS EVENTS OBSERVED. ACS AND IMPAIRED INTESTINAL MOTILITY IN GROUP I PATIENTS WERE TREATED BY USE OF CONSERVATIVE THERAPY. CONCLUSION: OWING TO THE USE OF INTRAPERITONEAL MESH AND DOSED APPOSING OF THE RECTUS ABDOMINIS MUSCLES, INTRAPERITONEAL ALLOPLASTY COMBINED WITH ANTERIOR COMPONENT SEPARATION TECHNIQUE FOR GIANT INCISIONAL VENTRAL HERNIA REPAIRS CONTRIBUTES TO A SIGNIFICANT REDUCTION IN THE INCIDENCE OF ABDOMINAL COMPARTMENT SYNDROME BY ENSURING OPTIMAL VOLUME OF THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739473 UNKNOWN PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other