BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7806324 · Received August 22, 2018

    Report

    Report Number
    2210968-2018-75332
    Event Type
    Injury
    Date Received
    August 22, 2018
    Report Date
    August 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (ETHIBOND 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 PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: J TRAUMA ACUTE CARE SURG. 2013; 74(6): 1486 1492. DOI: 10.1097/TA.0B013E3182924950. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2018-75332 IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (ETHIBOND 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 PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? RESPONSE RECEIVED FROM AUTHOR: THERE WAS NO COMPLICATION RELATED TO SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: NOT SO FAST TO SKIN GRAFT: TRANSABDOMINAL WALL TRACTION CLOSES MOST ¿¿DOMAIN LOSS¿¿ ABDOMENS IN THE ACUTE SETTING" AUTHORS: ANDREW DENNIS, DO, THOMAS A. VIZINAS, DO, MSC, KIMBERLY JOSEPH, MD, SAMUEL KINGSLEY, MD, FARAN BOKHARI, MD, FREDERIC STARR, MD, STATHIS POULAKIDAS, MD, DORION WILEY, MD, THOMAS MESSER, MD, AND KIMBERLY NAGY, MD, CITATION: J TRAUMA ACUTE CARE SURG. 2013; 74(6): 1486 1492. DOI: 10.1097/TA.0B013E3182924950. DAMAGE-CONTROL LAPAROTOMY (DCL) HAS REVOLUTIONIZED THE SURGERY OF INJURY. HOWEVER, THIS HAS LED TO THE DILEMMA OF THE NON-CLOSABLE ABDOMEN. SUBSEQUENTLY, THERE EXISTS A SUBGROUP OF PATIENTS WHO AFTER RESUSCITATION AND DIURESIS, REMAIN NON-CLOSABLE. BEFORE THE ADOPTION OF OUR OPEN ABDOMEN PROTOCOL (OAP) AND USE OF TRANSABDOMINAL WALL TRACTION (TAWT), THESE PATIENTS REQUIRED SKIN GRAFTING AND A PLANNED VENTRAL HERNIA. THE AUTHORS REPORTED THEIR EXPERIENCE WITH A MODIFICATION OF THE WITTMANN PATCH (WP) CLOSURE. RATHER THAN SUTURING THE WP DIRECTLY TO THE MEDIAL FASCIA, THE DEVICE IS ANCHORED TO THE UNDERSIDE OF THE ABDOMINAL WALL, LATERAL TO THE RECTUS SHEATH, USING EXTERNAL BOLSTERS. THE AUTHORS HYPOTHESIZED THAT THIS TECHNIQUE MORE EFFECTIVELY DISTRIBUTES MEDIAL TRACTION TO THE EXTERNAL OBLIQUE¿S, DEMONSTRATED BY PROGRESSIVE SHORTENING OF THE WOUND¿S WIDTH OVER TIME. A TOTAL OF 32 PATIENTS WERE INCLUDED IN THE TAWT PROTOCOL. DURING THE PROCEDURE, THE HOOK AND LOOP SHEETS ARE FIXED TO THE UNDERSIDE OF THE ABDOMINAL WALL BY ETHIBOND 5-0 POLYESTER SUTURES (ETHICON) RUNNING PARALLEL TO THE VASCULAR BUNDLE, AT THE LATERAL EDGE OF THE RECTUS SHEATH. THE SUTURES PENETRATE ALL LAYERS OF THE ABDOMINAL WALL, EFFECTIVELY SANDWICHING IT BETWEEN THE OVERLYING BOLSTERS. REPORTED COMPLICATIONS INCLUDED ENTEROCUTANEOUS FISTULA DEVELOPED AS AN ANASTOMOTIC LEAK (N-1) WHICH REQUIRED PRIMARY SUMP DRAINS AFTER ABDOMINAL CLOSURE, ENTEROCUTANEOUS FISTULA 3 WEEKS FOLLOWING TAWT REMOVAL (N-1) WHICH REQUIRED PRIMARY SUMP DRAINS AFTER ABDOMINAL CLOSURE, AND SMALL LOCALIZED PARTIAL THICKNESS SKIN BREAKDOWN OR NECROSIS (N-6) WHICH REQUIRED LOCAL WOUND CARE AND SILVER-SULFADIAZINE TOPICAL OINTMENT. OAP/TAWT HAS REVOLUTIONIZED THE WAY THE AUTHORS MANAGED ¿¿DOMAIN LOSS¿¿ OPEN ABDOMEN PATIENTS AND HAS VIRTUALLY ELIMINATED THE ACCEPTANCE OF PLANNED VENTRAL HERNIA. TAWT CONSISTENTLY RECAPTURES LOST DOMAIN, PRESERVES THE LEADING FASCIAL EDGE, AND ELIMINATES THE NEED FOR BIOLOGIC BRIDGES, COMPONENTS SEPARATION, OR SKIN GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647382 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention WHITMAN PATCH