BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6884485 · Received September 21, 2017

    Report

    Report Number
    3005075853-2017-05071
    Event Type
    Death
    Date Received
    September 21, 2017
    Date of Event
    August 1, 2004
    Report Date
    August 25, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 9/21/2017. BATCH # UNK. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH? WERE THERE ANY STAPLE FORMATION ISSUES NOTED IN INITIAL PROCEDURE OR REOPERATION?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: DOES THE SURGEON BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH? NO, THE SURGEON THINK CHOOSING THE WRONG CARTRIDGE, FOR THE SMALL INTESTINE, WHITE CARTRIDGE IS BETTER. WERE THERE ANY STAPLE FORMATION ISSUES NOTED IN INITIAL PROCEDURE OR REOPERATION? NO. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE RATIONALE THAT THE SURGEON USED THAT DEATH IS NOW NOT CONSIDERED RELATED TO DEVICE AS MENTIONED IN ARTICLE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REVIEW OF JOURNAL ARTICLE: FATAL FULMINANT PANCREATITIS AFTER LAPAROSCOPIC GASTRIC BYPASS. AUTHORS: CUNCHUAN WANG, YIXING REN, JUN CHEN, YOUZHU HU, JINGGE YANG, PENG XU, YUNLONG PAN, JINYI LI. CITATION: OBESITY SURGERY 2008;18:1498-1501. DOI 10.1007/S11695-008-9486-Y. THE AUTHORS REPORT ONE CASE THAT RESULTED IN DEATH DUE TO POSTOPERATIVE FULMINANT ACUTE PANCREATITIS AFTER LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGBP) WAS PERFORMED WHEN THIS PROCEDURE WAS STILL RELATIVELY NEW IN CHINA. THE PATIENT WAS A CHRONICALLY OBESE (B)(6) YEAR-OLD MALE. WEIGHT LOSS MEDICATIONS HAD BEEN INEFFECTIVE, AND PREOPERATIVE BODY MASS INDEX WAS 40.7. PREOPERATIVE EXAMINATION REVEALED MODERATE STEATOHEPATITIS. LAPAROSCOPIC RYGBP WAS PERFORMED USING AN ETS-FLEX45 ENDOSCOPIC LINEAR CUTTER WITH BLUE TR45B 3.8MM STAPLE CARTRIDGES. EARLY MANIFESTATIONS OF CLINICAL SHOCK APPEARED 13H AFTER THE LAPAROSCOPIC SURGERY. A SECOND LAPAROSCOPIC EXAMINATION SHOWED SMALL-VESSEL HEMORRHAGE AT THE POSTERIOR WALL OF THE JEJUNOJEJUNAL ANASTOMOSIS, WITH BLOOD CLOT FORMATION RESULTING IN ROUX LIMB AND AFFERENT LOOP OBSTRUCTION. FULMINANT ACUTE PANCREATITIS DEVELOPED IN THE PATIENT (B)(6) AFTER THE SECOND SURGERY. THE PATIENT DIED 15 DAYS LATER FROM SYSTEMIC MULTIORGAN INSUFFICIENCY DUE TO POSTOPERATIVE FULMINANT ACUTE PANCREATITIS. THE AUTHORS CONCLUDED THAT THE MAIN REASON MAY HAVE BEEN SMALL-VESSEL HEMORRHAGE AT THE POSTERIOR WALL OF THE JEJUNOJEJUNAL (JJ) ANASTOMOSIS. REGARDING THE CAUSE OF THE HEMORRHAGE, THE AUTHORS BELIEVE THAT IT WAS DIRECTLY RELATED TO THE TR45B 3.8MM STAPLE CARTRIDGES USED IN THE OPERATION. BECAUSE THE TR45B 3.8-MM STAPLE CARTRIDGE HAS FOUR STAPLE ROWS, THE DISTANCE BETWEEN THE STAPLES IS LARGE. ALSO, THE TISSUE THICKNESS AFTER STAPLE CLOSURE IS 1.5 MM, WHICH IS THICKER THAN THE WALL OF THE SMALL INTESTINE AND CANNOT GUARANTEE IDEAL CLOSURE OF SMALL SUBSEROSAL VESSELS. IN ADDITION, THE RYGBP CREATES A BLIND END IN THE ROUX LIMB, WHICH EASILY BECOMES A HIGH-PRESSURE ENVIRONMENT UNDER OUTLET OBSTRUCTION CONDITIONS. LASTLY, OBESE PATIENTS HAVE A HIGHER LIKELIHOOD OF DEVELOPING POSTOPERATIVE PANCREATITIS COMPARED WITH NORMAL INDIVIDUALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664677 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death