BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT

    MDR report key: 2546664 · Received April 20, 2012

    Report

    Report Number
    1835959-2012-00005
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    February 15, 2011
    Report Date
    April 20, 2012
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K062696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATED. DEVICE NOT RETURNED TO THE MANUFACTURER. THE DEVICE WAS ORIGINALLY PLACED FOR TREATMENT OF A GRADE 2-3 CYSTOCELE. PATIENT RETURNED APPROXIMATELY 1 MONTH LATER REPORTING PAIN. UPON GYNECOLOGICAL EXAMINATION, THE PHYSICIAN DIAGNOSED AN EROSION OF THE VAGINAL WALL DUE TO THE GRAFT MATERIAL. THE PATIENT'S MEDICAL RECORDS REVEAL THAT THE GRAFT WAS PLACED WITH 2-0 VICRYL INTERRUPTED SUTURES. THE VAGINAL EPITHELIUM WAS CLOSED WITH A 3-0 VICRYL RUNNING SUTURE. CBI BELIEVES THAT THE REPORT OF AN EROSION IS HIGHLY UNLIKELY. IT IS BELIEVED THAT THIS IS ACTUALLY A DEHISCENCE OF THE VAGINAL INCISION WITH THE RUNNING SUTURE FAILING AND THE GRAFT MATERIAL BEING EXPOSED. THE "PROCEDURE GUIDE FOR UTEROSACRAL LIGAMENT FIXATION" NOTES THAT "INTERRUPTED SUTURES SHOULD BE USED IN THIS APPLICATION" NOT THE RUNNING STITCH WHICH WAS USED IN THIS PATIENT. IF AN IMPROPER SUTURE TECHNIQUE WAS EMPLOYED, THE DEHISCENCE WOULD BE MORE LIKELY TO OCCUR EXPOSING THE MATERIAL. CBI BELIEVES THE GRAFT PERFORMED ACCORDING TO SPECIFICATION. DUE TO THE REGULATORY CLIMATE SURROUNDING PELVIC ORGAN PROLAPSE (POP) AND THE USED OF BIOLOGIC AND SYNTHETIC MESH TO TREAT ISSUES DEALING WITH THE PELVIC FLOOR, COOK BIOTECH BELIEVED IT WOULD BE PRUDENT TO FILE AN MDR FOR THIS CASE.

    Description of Event or Problem · 1

    CMI RECEIVED A CLAIM CONCERNING THE SURGISIS ES 4X7 GRAFT WHICH WAS USED TO TREAT A 2-3 GRADE CYSTOCELE ON (B)(6) 2010. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH "EROSION OF GRAFT MATERIAL." THE GRAFT WAS EXPLANTED ON (B)(6) 2011. PATIENT RECORDS REVEALED THAT THE DEVICE USED WAS THE J-PF-8X13. THE PATIENT IS CONTEMPLATING ADDITIONAL EXCISION PROCEDURES WITH HER HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH LB453757

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization