BEUDAMED
    FDA Adverse Event Death Summary report: N

    EEA 25MM SINGLE-USE STAPLER

    MDR report key: 5603859 · Received April 25, 2016

    Report

    Report Number
    2647580-2016-00172
    Event Type
    Death
    Date Received
    April 25, 2016
    Report Date
    April 11, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CITATION: SURG ENDOSC 30(4):1692-8, 2016 APR. DOI 10.1007/S00464-015-4343-2 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE REPORT: ABSTRACT: MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) IS GAINING INCREASING POPULARITY IN THE TREATMENT OF ESOPHAGEAL CANCER. IN FACT, WHILE SURGICAL AND ONCOLOGIC OUTCOMES ARE NOT INFERIOR TO THOSE ACHIEVED THROUGH A TRADITIONAL OPEN APPROACH, PATIENTS UNDERGOING MIE BENEFIT FROM SHORTER LENGTH OF STAY, LESSER PAIN AND PROMPTER RECOVERY. THIS TECHNIQUE IS, HOWEVER, HIGHLY CHALLENGING, AND THE DEVELOPMENT OF A MIE PROGRAM, EVEN IN THE SETTING OF A TERTIARY CENTER, REQUIRES TIME AND PROGRESSIVE HONING OF SURGICAL SKILLS. METHODS : WE USE A MINIMALLY INVASIVE IVOR LEWIS APPROACH. THE ABDOMINAL PHASE OF THE PROCEDURE INCLUDES COMPLETE CELIAC LYMPHADENECTOMY AND TUBULARIZATION OF THE STOMACH, WHICH WILL CONSTITUTE THE NEO-ESOPHAGUS. THE VIDEO-ASSISTED THORACOSCOPIC SURGERY PORTION OF THE OPERATION TAKES PLACE IN LEFT LATERAL DECUBITUS AND ALLOWS FOR OPTIMAL THORACIC LYMPHADENECTOMY AND ANASTOMOSIS. RESULTS : FROM (B)(6) 2011 TO (B)(6) 2015, WE TREATED 52 PATIENTS WITH THE ABOVE-DESCRIBED PROCEDURE. THE EVOLUTION OF OUR ANASTOMOTIC TECHNIQUE INCLUDED A FIRST GROUP OF CIRCULAR STAPLED ANASTOMOSIS WITH ORVILTM AND 3.5-MM EEATM (N = 16 PATIENTS), SUBSEQUENTLY ABANDONED IN FAVOR OF A LINEAR ANASTOMOSIS (N = 12), BEFORE GOING BACK TO THE ORVILTM COUPLED WITH 4.8-MM EEATM (N = 22) IN MORE RECENT TIMES. THERE WERE ALSO AN ADDITIONAL TWO ANASTOMOSES THAT DID NOT FALL UNDER ANY OF THESE CATEGORIES. WE EXPERIENCED TWO POSTOPERATIVE DEATHS. THE OVERALL LEAK RATE WAS 14 %, BUT FELL DOWN TO 4 % IN THE LAST GROUP. MEDIAN LOS WAS 9 DAYS. LYMPH NODE RETRIEVAL WAS ADEQUATE THROUGHOUT THE WHOLE SERIES. CONCLUSIONS DEVELOPING A MIE PROGRAM REQUIRES A SIGNIFICANT LEARNING CURVE BEFORE THE RESULTS PLATEAU. ONLY ONCE A TECHNIQUE OF CHOICE IS REFINED AND MASTERED, THE ADVANTAGES GRANTED BY MIE BECOME APPARENT. ESOPHAGECTOMY REPRESENTS THE MAINSTAY FOR TREATMENT OF ESOPHAGEAL CANCER WHILE ALSO CONSTITUTES A VALUABLE OPTION FOR TREATMENT OF ADVANCED BENIGN ESOPHAGEAL DISEASE. DESPITE SEVERAL ADVANCEMENTS IN TECHNOLOGY AND SURGICAL TECHNIQUE THROUGHOUT THE LAST DECADES, THIS PROCEDURE REMAINS BURDENED BY NON-NEGLIGIBLE MORTALITY AND MORBIDITY. IN THE USA, THE MORTALITY RATE FOR ESOPHAGECTOMY HAS BEEN REPORTED TO RANGE FROM 8 TO 23 % AND IT IS INVERSELY CORRELATED WITH THE HOSPITAL VOLUME [1]. IN AN EFFORT TO IMPROVE SURGICAL OUTCOMES FOR THIS PROCEDURE, AN ATTEMPT WAS MADE TO APPLY MINIMALLY INVASIVE TECHNIQUES TO ESOPHAGECTOMY IN THE EARLY 1990S, LEADING TO THE FIRST DESCRIPTION OF THORACOSCOPIC ESOPHAGECTOMY BY CUSCHIERI ET AL. [2]. SINCE THEN, A MINIMALLY INVASIVE COUNTERPART HAS BEEN DEVELOPED FOR EACH OF THE THREE MOST COMMON APPROACHES FOR ESOPHAGECTOMY: TRANSHIATAL, IVOR LEWIS AND MCKEOWN ESOPHAGECTOMY [3-5]. IN ADDITION, A BROAD VARIETY OF MODIFIED, HAND-ASSISTED AND HYBRID APPROACHES HAVE BEEN DESCRIBED AS WELL. CURRENTLY, MANY CENTERS AROUND THE WORLD HAVE ADOPTED AND REFINED MIE, AND RANDOMIZED DATA HAVE CONFIRMED ITS ADVANTAGES OVER OPEN ESOPHAGECTOMY IN TERMS OF DECREASED PULMONARY INFECTIONS, SHORTER HOSPITAL STAY AND BETTER QUALITY OF LIFE [6]. MOST IMPORTANTLY, ONCOLOGIC OUTCOMES AFTER MIE HAVE BEEN DEMONSTRATED TO BE EQUIVALENT TO OPEN PROCEDURES [7, 8]. MIE IS A TECHNICALLY CHALLENGING PROCEDURE, REQUIRING ADVANCED MINIMALLY INVASIVE SURGICAL SKILLS AND A CONSIDERABLY LONG LEARNING CURVE BEFORE A PLATEAU OF OPTIMAL OUTCOMES IS REACHED. THE AIM OF THE PRESENT WORK IS TO DESCRIBE THE IMPLEMENTATION OF A NEW MIE PROGRAM AT (B)(6) UNIVERSITY, OUTLINING THE EVOLUTION IN THE TECHNIQUE, WHICH HAS LED TO PROGRESSIVE IMPROVEMENTS IN OUTCOMES OVER TIME. FOLLOW-UP INFORMATION FROM THE AUTHOR: THE PHYSICIAN CONFIRMED THE PATIENT'S CAUSE OF DEATH WAS FROM COMPLICATIONS SECONDARY TO RADIATION PNEUMONITIS AND WAS NOT CAUSALLY RELATED TO THE DEVICE. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258568 EEA 25MM SINGLE-USE STAPLER IMPLANTABLE STAPLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA25 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death