BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 25088603 · Received May 5, 2026

    Report

    Report Number
    1000306051-2026-00041
    Event Type
    Death
    Date Received
    May 5, 2026
    Date of Event
    March 28, 2026
    Report Date
    May 4, 2026
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: FOWLER, CODY C. MD; RAINE, BRIELLE E. MD; ZARONIAS, CALLISTA BS; BELL, DEREK E. MD. INCISIONAL VENTRAL HERNIA REPAIR IN THE LIVER TRANSPLANT POPULATION¿IS BIOLOGICAL MESH WORTH THE RISK? A SINGLE SURGEON EXPERIENCE. ANNALS OF PLASTIC SURGERY ():10.1097/SAP.0000000000004751, APRIL 13, 2026. DOI: 10.1097/SAP.0000000000004751. THIS EVENT IS BEING REPORTED AS A DEATH DUE TO THE REPORTED "1 PATIENT DIED FROM COMPLICATIONS OF THEIR [POSTOPERATIVE MESH] INFECTION." MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT INCLUDING PATIENT-SPECIFIC INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. WITHOUT THE LOT NUMBER(S), AN INTERNAL INVESTIGATION COULD NOT BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE REMAINING SERIOUS INJURIES REPORTED AGAINST THE MESH COHORT WILL BE REPORTED UNDER ABBVIE PATIENT IDENTIFIER: (B)(4).

    Description of Event or Problem · 0

    ABBVIE BECAME AWARE OF A PUBLICATION FROM THE US TITLED "INCISIONAL VENTRAL HERNIA REPAIR IN THE LIVER TRANSPLANT POPULATION-IS BIOLOGICAL MESH WORTH THE RISK? A SINGLE SURGEON EXPERIENCE¿. THIS RETROSPECTIVE STUDY OF ONE SURGEON'S LIVER TRANSPLANT PATIENTS WHO UNDERWENT INCISIONAL VENTRAL HERNIA REPAIR BETWEEN 01/JAN/2016 AND 25/FEB/2024. THE STUDY INCLUDED 36 PATIENTS- 20 PATIENTS HAD REPAIRS PERFORMED WITHOUT MESH AND 16 WITH BIOLOGICAL MESH. THE BIOLOGICAL MESHES USED WERE STRATTICE (N=6), OVITEX (N=8), AND FLEXHD (N=2). OVITEX AND FLEXHD ARE NON-ABBVIE PRODUCTS. THE STUDY AUTHORS REPORT THAT "1 PATIENT DIED FROM COMPLICATIONS OF THEIR [POSTOPERATIVE MESH] INFECTION." NO SPECIFIC DETAILS ABOUT WHICH MESH WAS USED IN THE PATIENT WHO DIED. NO OTHER DETAILS REGARDING THIS PATIENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561928 UNKNOWN STRATTICE MESH, SURGICAL FTM LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death