BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT

    MDR report key: 8698498 · Received June 13, 2019

    Report

    Report Number
    2210968-2019-82739
    Event Type
    Injury
    Date Received
    June 13, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K113004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT 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 PRODUCT USED IN THIS PROCEDURE? CITATION: PLAST RECONSTR SURG GLOB OPEN 2017;5:E1572; DOI:10.1097/GOX.0000000000001572; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: STRATAFIX FOR ABDOMINAL WALL REPAIR FOLLOWING ABDOMINAL FLAP HARVEST. AUTHOR/S: SHOKO YASUDA, MD; KOICHI TOMITA, MD, PHD; KOICHIRO KIYA, MD, PHD; KO HOSOKAWA, MD, PHD CITATION: PLAST RECONSTR SURG GLOB OPEN 2017;5:E1572; DOI:10.1097/GOX.0000000000001572; FROM JANUARY THROUGH MAY 2017, THE AUTHORS PERFORMED ABDOMINAL WALL REPAIR WITH STRATAFIX (ETHICON) IN THEIR INSTITUTION ON 18 PATIENTS. EIGHT PATIENTS (7 MALE AND 1 FEMALE; MEAN AGE: 71 YEARS) UNDERWENT A VERTICAL RECTUS ABDOMINIS MYOCUTANEOUS (VRAM) FLAP, AND 10 FEMALE PATIENTS (MEAN AGE: 47 YEARS) UNDERWENT DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR (DIEP) FLAP. FOR PATIENTS IN THE VRAM FLAP GROUP, THE ANTERIOR SHEATH OF THE RECTUS ABDOMINIS WAS PARTIALLY RESECTED, WHICH MEANT THAT THE SUTURES REQUIRED HIGH TENSION. THE ANCHORS OF THE STRATAFIX (ETHICON) SECURELY GRIPPED THE FASCIA, SO EVEN AREAS WITH HIGH TENSION WERE GRIPPED WELL AND EASILY SUTURED TOGETHER. REPORTED COMPLICATIONS IN THE VRAM FLAP GROUP INCLUDED ABDOMINAL WALL HERNIA (N-1). THE ABDOMINAL WALL HERNIA MAY HAVE BEEN DUE TO THE FACT THAT, IN ADDITION TO THE PATIENT'S ADVANCED AGE, A LARGE PORTION OF THE ANTERIOR SHEATH HAD BEEN HARVESTED, SO THE SUTURE BITE MAY HAVE BEEN TOO SHORT. COMPARED WITH THE CONVENTIONAL RUNNING SUTURES OR INTERRUPTED SUTURES, BOTH OF WHICH CREATE HIGH TENSION AT THE POINT OF INSERTION, SUTURING WITH STRATAFIX IS HIGHLY ADVANTAGEOUS IN THAT THE TISSUE IS MUCH LESS LIKELY TO TEAR. IN ADDITION, AS THERE IS HARDLY ANY BACKSLIDING OF THE SUTURE THREAD, THERE IS NO NEED TO PULL, SO NO ASSISTANCE IS NEEDED TO CLOSE UP WOUNDS WITH HIGH TENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491502 STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1