BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1171088 · Received September 18, 2008

    Report

    Report Number
    2024601-2008-00729
    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: 09/18/2008. 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 INFORMATION 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. FURTHER INFORMATION FROM THE REPORTER REGARDING SERIAL NUMBER AND IMPLANT DATE HAS BEEN REQUESTED. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AND VOMITING 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."

    Description of Event or Problem · 1

    REPORTED AS: "UP TO 2004 FIVE PATIENTS (17.2%) UNDERWENT FURTHER SURGERY FOR FAILURE OR COMPLICATIONS AFTER REDO PROCEDURES. ONE REQUESTED BAND REMOVAL AFTER 3 MONTHS AND REFUSED TO SWITCH TO ANOTHER PROCEDURE. ONE UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY AFTER 36 MONTHS FROM REOPERATION FOR INSUFFICIENT WEIGHT LOSS. THREE PATIENTS EXPERIENCED RECURRENT SLIPPAGE AFTER 1, 6, AND 12 MONTHS, RESPECTIVELY." FROM LITERATURE REVIEW: JOURNAL ARTICLE "LAPAROSCOPIC GASTRIC REBANDING FOR SLIPPAGE WITH POUCH DILATION: RESULTS ON 29 CONSECUTIVE PATIENTS", MIRTO FOLETTO, PAOLO BERNANTE, LUCA BUSETTO, FABIO POMERRI, GIANLUCA VECCHIATO, LUCA PREVEDELLO, STEFANIA FAMENGO, DONATO NITTI, CLINICA CHIRURGICA II, PADUA UNIVERSITY, PADOVA, 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