BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2085314 · Received April 26, 2011

    Report

    Report Number
    2024601-2011-00356
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    February 19, 2010
    Report Date
    March 29, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE DATE SPAN OF THE STUDY PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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. EROSION 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 EROSION AS FOLLOWS: "AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT." "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. EROSION OF THE BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY AFTER THE USE OF GASTRIC-IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AND AFTER EXTENSIVE DISSECTION OR USE OF ELECTROCAUTERY, AND DURING EARLY EXPERIENCE."

    Description of Event or Problem · 1

    REPORTED EVENTS OF BAND EROSION FROM JOURNAL ARTICLE: "SAFETY, EFFICACY, AND DURABILITY OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN A SINGLE SURGEON U.S. COMMUNITY PRACTICE", SURGERY FOR OBESITY AND RELATED DISEASES (2011) 140-144. THIS MEDWATCH REPRESENTS THE 2 PTS MENTIONED IN THE ARTICLE WHO WERE DIAGNOSED WITH "BAND EROSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention