BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1171133 · Received September 18, 2008

    Report

    Report Number
    2024601-2008-00692
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BIOENTERICS CORP
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON 18/SEP/08. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFO FROM THE REPORTER REGARDING SERIAL NUMBER AND IMPLANT DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF BAND SLIPPAGE AS FOLLOWS: "OVER DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "THE DISSECTION SHOULD BE THE SAME SIZE AS THE BAND OR EVEN SMALLER TO REDUCE THE POSSIBILITY OF BAND AND/STOMACH SLIPPAGE."

    Description of Event or Problem · 1

    REPORTED AS: "BETWEEN 1999 AND 2007, 540 LAGB'S HAVE BEEN PERFORMED IN 133 MEN AND 407 WOMEN. MEAN HOSPITAL STAY HAS BEEN 2.5 DAYS. MORTALITY HAS BEEN ZERO. MAJOR COMPLICATIONS INCLUDED 19 SLIPPAGES, 7 OUTLET OBSTRUCTIONS, 1 INTRAGASTRIC MIGRATION, 2 ESOPHAGEAL DILATATIONS, 7 BAND INTOLERANCES. SLIPPAGE REQUIRED REMOVAL IN 12 CASES; IN 5 PATIENTS, A NEW BAND REPOSITIONED; IN ONE PT, A GASTRIC REDUCTION WAS PERFORMED; AND IN ONE, A SLEEVE GASTRECTOMY. WE ROUTINELY USED THE 9.75 CM LAPBAND IN THE FIRST PHASE, AND LATELY (SINCE 2005) THE 11 CM BAND." FROM LITERATURE REVIEW: JOURNAL ABSTRACT: "LAPAROSCOPIC ESOPHAGO-GASTRIC BANDING: HOW TO PREVENT AND DEAL WITH COMPLICATIONS" S. BOSCHI, ET AL, BOLOGNA, ITALY. PUBLISHED IN "OBES SURG 2008" SPRINGER SCIENCE.

    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 NI Required Intervention