BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 25MM SINGLE-USE STAPLER

    MDR report key: 5610100 · Received April 26, 2016

    Report

    Report Number
    2647580-2016-00185
    Event Type
    Injury
    Date Received
    April 26, 2016
    Report Date
    April 11, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE. THE ASSOCIATED CASE NUMBERS ARE: (B)(4) (DEATH, SEPTIC SHOCK), (B)(4) (DEATH, COMPLICATIONS FOLLOWING MAJOR HEMORRHAGE), (B)(4) (ANASTOMOTIC LEAK), (B)(4) (ANASTOMOTIC LEAK), (B)(4) (ANASTOMOTIC LEAK) AND (B)(4) (ANASTOMOTIC LEAK). CITATION: J GASTROINTEST SURG (2016) 20:688¿692 DOI 10.1007/S11605-016-3087-1.

    Description of Event or Problem · 1

    ACCORDING TO A LITERATURE REPORT: INTRODUCTION: REPORTS ON OUTCOMES AFTER DOUBLE-STAPLE TECHNIQUE (DST) FOR TOTAL AND PROXIMAL GASTRECTOMY ARE LIMITED, ORIGINATING MOSTLY FROM ASIAN CENTERS. OUR OBJECTIVE WAS TO EXAMINE ANASTOMOTIC LEAK AND STRICTURE WITH DST FOR ESOPHAGOENTERIC ANASTOMOSIS IN GASTRIC CANCER PATIENTS. METHODS: A SINGLE INSTITUTION REVIEW WAS PERFORMED FOR PATIENTS WHO UNDERWENT TOTAL/PROXIMAL GASTRECTOMY WITH DST BETWEEN 2006 AND 2015. DST WAS PERFORMED USING TRANSORAL ANVIL DELIVERY (ORVIL) WITH END-TO-END ANASTOMOSIS. CLINICAL CHARACTERISTICS AND OUTCOMES, INCLUDING ANASTOMOTIC LEAK AND STRICTURE, WERE RECORDED. RESULTS: OVERALL, DST WAS PERFORMED IN 60 PATIENTS [TOTAL GASTRECTOMY (81.7 %, N = 49/60), PROXIMAL GASTRECTOMY (10.0 %, N=6/ 60), AND COMPLETION GASTRECTOMY (8.3 %, N =5/60)]. NEOADJUVANT CHEMOTHERAPY WAS ADMINISTERED TO 21 PATIENTS (35.0 %), AND 6 PATIENTS (10.0 %) RECEIVED EXTERNAL BEAM RADIATION THERAPY PRIOR TO COMPLETION GASTRECTOMY. OPERATIVE APPROACH WAS OPEN (51.7 %, N= 31/60), LAPAROSCOPIC (43.3 %, N =26/60), OR ROBOTIC (5.0 %, N = 3/60). ANASTOMOTIC LEAK OCCURRED IN 6.7 % (N=4/ 60), WHILE STRICTURE INDEPENDENT OF LEAK WAS IDENTIFIED IN 19.0 % (N =11/58) OF PATIENTS. COMPLICATIONS OCCURRED IN 38.3 %(N =23/60) OF PATIENTS, OF WHICH 52 % WERE CLASSIFIED AS CLAVIEN-DINDO GRADES III - V COMPLICATIONS. CONCLUSION IN THE LARGEST WESTERN SERIES OF DST FOR ESOPHAGOENTERIC ANASTOMOSES IN GASTRIC CANCER SURGERY, OUR EXPERIENCE DEMONSTRATES THAT DST IS SAFE AND EFFECTIVE WITH LOW RATES OF LEAK AND STRICTURE. [...]THERE WERE TWO POSTOPERATIVE DEATHS IN THE SERIES: ONE WAS DUE TO SEPTIC SHOCK AND THE SECOND DUE TO COMPLICATIONS FOLLOWING MAJOR HEMORRHAGE.[...] FOUR ANASTOMOTIC LEAKS WERE REPORTED: (B)(4) [CT-GUIDED DRAINAGE AND ANTIBIOTICS], (B)(4) [STENT PLACEMENT], (B)(4) [STENT PLACEMENT] AND (B)(4) [REOPERATION]. ALTHOUGH THESE PATIENTS HAD A NEGATIVE ESOPHAGOGRAM OR UPPER ENDOSCOPY 3 DAYS POSTOPERATIVELY, ALL FOUR PATIENTS WERE EVENTUALLY DIAGNOSED WITH ANASTOMOTIC LEAK BY COMPUTED TOMOGRAPHY (CT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262475 EEA 25MM SINGLE-USE STAPLER IMPLANTABLE STAPLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA25 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R