BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7651563 · Received June 29, 2018

    Report

    Report Number
    2210968-2018-73946
    Event Type
    Injury
    Date Received
    June 29, 2018
    Report Date
    June 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: LARYNGOSCOPE. 2010; 120:731 733. DOI: 10.1002/LARY.20826. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ADJUSTABLE LATEROFIXATION OF THE VOCAL FOLD IN BILATERAL VOCAL FOLD PARALYSIS" AUTHORS: WALEED F. EZZAT, MD; MOHAMMED SHEHATA, MD; IHAB KAMAL, MD; MAGDY AMIN RIAD, MD, FRCS CITATION: LARYNGOSCOPE. 2010; 120:731 733. DOI: 10.1002/LARY.20826 THE OBJECTIVES OF THIS PROSPECTIVE CASE STUDY WAS TO DESCRIBE A MODIFICATION OF VOCAL FOLD (VF) LATEROFIXATION IN PATIENTS WITH BILATERAL VF PARALYSIS (VFP), WHICH ALLOWS ADJUSTING THE SUTURES TENSION ACCORDING TO VOICE AND AIRWAY PATENCY IN THE FIRST POST-OPERATIVE DAY. A TOTAL OF 21 PATIENTS WITH RECENT BILATERAL VFP WERE TREATED BY THE MODIFIED LATEROFIXATION TECHNIQUE IN AIN-SHAMS UNIVERSITY HOSPITALS BETWEEN MAY 2007 AND FEBRUARY 2009. THERE WERE 8 MALE PATIENTS AND 13 FEMALES WERE INCLUDED. THE MEDIAN AGE OF THE GROUP WAS 36 YEARS. DURING THE SURGICAL PROCEDURE, THE TROCARS OF THE CANNULA WERE REMOVED AND A PROLENE 2 0 SUTURE ON A STRAIGHT, SHORT NEEDLE WAS INTRODUCED INTO THE LOWER CANNULA FROM OUTSIDE. ONCE THE EDGE OF THE NEEDLE WAS RECOGNIZED UNDER THE OPERATIVE MICROSCOPE IT WAS GRASPED BY A REGULAR MICROLARYNGEAL NEEDLE HOLDER. IT WAS THEN REDIRECTED TO PASS THROUGH THE UPPER CANNULA FROM WITHIN THE AIRWAY TO THE OUTSIDE. A SINGLE THREAD FORMED A LOOP AROUND THE VOCAL FOLD. WITH THE TWO ENDS OF THE SUTURE NOW BEING EXTERNAL, THE LOOP WAS PULLED UNTIL THE VOCAL FOLD WAS SUFFICIENTLY LATERALIZED. THE ENDS OF THE SUTURE WERE TIED EXTERNALLY OVER A PIECE OF GAUZE AND THE PATIENT WAS AWAKENED. THE NEXT DAY WHEN THE PATIENT WAS FULLY CONSCIOUS AND UNDER FLEXIBLE ENDOSCOPIC LARYNGOSCOPY, THE SUTURE WAS TIED TO A SUITABLE TENSION ACCORDING TO THE VOICE AND AIRWAY PREFERENCES OF THE PATIENT. THE SUTURE WAS THEN BURIED AFTER SIX TO EIGHT KNOTS WERE MADE. REPORTED COMPLICATIONS INCLUDED LOOSENING OF THE KNOTS AND LOSS OF SUTURE TENSION (N-1) WHICH REQUIRED REVISION SURGERY AND PROCEDURE FAILED TO ACHIEVE A SATISFACTORY LARYNGEAL AIRWAY (N-1), IN WHOM DECANNULATION OF THE TRACHEOTOMY WAS NOT ACHIEVED. AT 6 MONTHS POST-SURGERY, OTHER REPORTED COMPLICATIONS INCLUDED VF MOVEMENTS (N-2) IN WHICH THE SUTURES WERE REMOVED UNDER LOCAL ANESTHESIA BY REOPENING THE NECK INCISION AND CUTTING THE KNOT WITH REMOVAL OF THE STITCH, LATERAL MIGRATION OF THE LOOPED SUTURE (N-1), AND GRANULOMA (N-1). IT WAS REPORTED THAT IN PATIENTS WHERE NO MOVEMENT WAS OBSERVED, THE SUTURE WAS LEFT IN SITU FOR AT LEAST 1 YEAR, PENDING DEFINITIVE PROCEDURES. IT WAS CONCLUDED THAT THE MODIFIED LATEROFIXATION TECHNIQUE IS A RELIABLE FIRST LINE TREATMENT FOR RECENT BILATERAL VFP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495616 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention