BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9946654 · Received April 9, 2020

    Report

    Report Number
    2210968-2020-02881
    Event Type
    Injury
    Date Received
    April 9, 2020
    Report Date
    March 17, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, 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 ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) 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 (VICRYL SUTURE) USED IN THIS PROCEDURE? WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS 15 (2019) 100532. DOI: HTTPS://DOI.ORG/10.1016/J.AJOC.2019.100532. (B)(4).

    Description of Event or Problem · 1

    TITLE:GRAFTING OF AN AUTOLOGOUS TISSUE-ENGINEERED HUMAN CORNEAL EPITHELIUM TO A PATIENT WITH LIMBAL STEM CELL DEFICIENCY (LSCD). THE PURPOSE OF THE PRESENT WORK WAS TO REGENERATE A HEALTHY OCULAR SURFACE ON THE EYE OF A PATIENT SUFFERING FROM UNILATERAL LSCD BY TRANSPLANTATION OF A CULTURED AUTOLOGOUS CORNEAL EPITHELIUM (CACE). THIS CASE REPORT INVOLVES (B)(6) YEAR OLD FEMALE PATIENT WITH MARKED HERPES ZOSTER OPHTHALMICUS NEUROTROPHIC KERATITIS WITH SECONDARY CALCIFIC BAND KERATOPATHY AND PROGRESSIVE THINNING OF THE WHOLE CORNEA IN THE LEFT EYE WHO UNDERWENT LEFT CORNEAL PERFORATION. DURING THE PROCEDURE, A 360° LIMBAL PERITOMY WAS PERFORMED ON THE PATIENT'S DISEASED LEFT EYE AND THE FIBROVASCULAR CORNEAL PANNUS CAREFULLY REMOVED. A CIRCULAR SHEET OF CACE WITH A DIAMETER OF 14MM WAS TRANSFERRED TO THE SURFACE OF THE FRESHLY DE-EPITHELIALIZED CORNEA, COMPLETELY COVERING THE LIMBUS. IT WAS SUTURED WITH INTERRUPTED 10-0 POLYGLACTIN 910 (VICRYL; ETHICON). IN THE CACE, EPITHELIAL CELLS GENERATED A PSEUDO-STRATIFIED EPITHELIUM COMPOSED OF 3¿4 LAYERS. THE GRAFT WAS COMPLETELY COVERED WITH AN AMNIOTIC MEMBRANE ALSO ATTACHED WITH INTERRUPTED 10-0 POLYGLACTIN 910 (VICRYL; ETHICON) SUTURES. A MONTH AND A HALF AFTER THE CACE GRAFT, THE PATIENT DEVELOPED A STAPHYLOCCOCUS EPIDERMIDIS CORNEAL ULCER, INFERIORLY, IN AN AREA OF CORNEAL EXPOSURE. IT HEALED RAPIDLY USING MOXIFLOXACIN, FORTIFIED CEFAZOLIN, AND FORTIFIED TOBRAMYCIN. BECAUSE OF THE RESIDUAL INFLAMMATION, IT TOOK 1.5 MONTHS FOR THE CORNEAL EPITHELIUM TO HEAL COMPLETELY. THIS STUDY HAVE SHOWN THAT CACE HAS THE ABILITY TO RECOLONIZE THE CORNEAL SURFACE INCLUDING THE LIMBUS ONCE GRAFTED TO AN EYE WITH LSCD, THUS PROVIDING PERMANENT RESTORATION OF A SELF-RENEWING CORNEAL EPITHELIUM. COMBINED WITH THE PENETRATING KERATOPLASTY, THE TWO PROCEDURES REESTABLISHED A USEFUL VISION TO THE PATIENT. THE METHODS USED IN THIS CASE REPORT CAN THEREFORE PROVIDE A SOLUTION TO UNILATERAL LSCD PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409236 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention