BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1222583 · Received November 5, 2008

    Report

    Report Number
    2024601-2008-00834
    Event Type
    Death
    Date Received
    November 5, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BIOENTERICS CORP
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. NO AUTOPSY REPORT IS AVAILABLE FROM THE SURGEON. THE DEVICE WAS EXPLANTED BUT WILL NOT BE RETURNED TO ALLERGAN. BAND SLIPPAGE, OBSTRUCTION, INFECTION AND CARDIOPULMONARY ARREST ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE AND OBSTRUCTION AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." "IF THERE IS TOTAL STOMAL OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OF YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED. DEVICE LABELING ADDRESSED THE POSSIBLE OUTCOME OF DEATH AS FOLLOWS: "LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LA-BAND SYSTEM IS MAJOR SURGERY AND DEATH CAN OCCUR."

    Description of Event or Problem · 1

    REPORTED BY A HEALTH PROFESSIONAL AS: "A LAP-BAND DEATH. A PT EXPIRED AFTER A SLEEVE GASTRECTOMY WHICH WAS PERFORMED AFTER A BAND REMOVAL." FOLLOW UP WITH THE QUALITY ASSURANCE PROFESSIONAL AT THE HOSP REVEALS: "THE PT HAD A BAND SLIPPAGE AND REMOVAL WITH CONVERSION TO A SLEEVE GASTRECTOMY. THE PT DEVELOPED A PERITONEAL ABSCESS WITH DRAINS, WAS SEEN IN THE ER, RELEASED, AND RETURNED 24 HOURS LATER IN FULL ARREST. THE PT EXPIRED. WE ASKED THE DR IF THIS WAS DEVICE RELATED AND HE TOLD US THAT THERE WASN'T A PROBLEM WITH A DEVICE, IT JUST SLIPPED. THE PT HAD AN ENORMOUS AMOUNT OF ADHESIONS. HE DOES NOT KNOW WHY THE BAND SLIPPED OR WHY THE PT HAD THE ABSCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death