BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7384895 · Received March 30, 2018

    Report

    Report Number
    2210968-2018-71795
    Event Type
    Injury
    Date Received
    March 30, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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 FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY DEFICIENCY OF THE ETHICON PRODUCT VICRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: EUR J PLAST SURG. 2014; 37: 683 686. DOI: 10.1007/S00238-014-1004-Y. [(B)(4)].

    Description of Event or Problem · 1

    TITLE: POST-RADIATION TRACHEOESOPHAGEAL FISTULA FOLLOWING SALVAGE LARYNGECTOMY: MICROSURGICAL REPAIR USING A ¿BI-LAMINAR¿ LATERAL ARM FLAP. IT WAS REPORTED IN A JOURNAL ARTICLE: TRACHEOESOPHAGEAL FISTULAS (TOFS) MAY OCCUR FOLLOWING CREATION OF A FISTULA FOR SPEECH, TUMOR RECURRENCE OR SURGERY, PARTICULARLY WITH A HISTORY OF LOCAL IRRADIATION. RESECTION OF ADVANCED OR RECURRENT MALIGNANCIES OF THE UPPER AERODIGESTIVE TRACT OFTEN REQUIRES ADVANCED RECONSTRUCTIVE PROCEDURES, WHICH ARE FRAUGHT WITH SIGNIFICANT MORBIDITY AND MORTALITY, LEADING TO INCREASED HOSPITAL STAYS, DELAYS IN ORAL FEEDING, POST-OPERATIVE MORBIDITY AND NEGATIVE IMPACT ON QUALITY OF LIFE. A (B)(6)-YEAR-OLD MAN WHO UNDERWENT 2 PREVIOUS COURSES OF RADIOTHERAPY, SALVAGE TOTAL LARYNGECTOMY, AND NECK DISSECTION FOR RECURRENT SQUAMOUS CELL CARCINOMA WAS PRESENTED WITH A PERSISTENT TOF FOLLOWING TRANSESOPHAGEAL PUNCTURE FOR SPEECH VOICE REHABILITATION. DURING THE CLOSURE OF THE ESOPHAGEAL DEFECT, A VICRYL 3-0 SUTURE WERE PLACED FIRST AT THE MOST SUPERIOR AND INFERIOR ASPECT OF THE DEFECT WITH THE KNOTS WITHIN THE MUCOSAL SURFACE. REPORTED COMPLICATION INCLUDED A SMALL LEAK FROM A GAP IN THE REPAIR AT THE JUNCTION OF THE FLAP AND ESOPHAGEAL WALL SUPERIORLY, WHICH WAS SUCCESSFULLY RE-SUTURED WITH NO FURTHER INTERVENTION. IT WAS CONCLUDED THAT MICROSURGICAL RECONSTRUCTION PROVIDES AN ALTERNATIVE AND IMPORTANT ADJUNCT IN SALVAGE REPAIR OF PERSISTENT AND LARGE TOFS. THIS IS THE FIRST DESCRIPTION USING THE LATERAL FOREARM FLAP, FASHIONED TO PROVIDE A BI-LAMINAR RECONSTRUCTION FOR SALVAGE REPAIR WITH MINIMAL DONOR SITE MORBIDITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229906 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention