BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2739254 · Received September 7, 2012

    Report

    Report Number
    2024601-2012-00810
    Event Type
    Injury
    Date Received
    September 7, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP WITH THE AUTHORS OF THE ABSTRACT IS NOT POSSIBLE SINCE NO CONTACT INFO WAS PROVIDED; THEREFORE, WE WERE UNABLE TO REQUEST RETURN OF THE DEVICE. 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. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. EROSION AND POUCH DILATATION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF POUCH DILATATION AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR."

    Description of Event or Problem · 1

    ABSTRACT RECEIVED FROM ALLERGAN (B)(4), GLOBAL LITERATURE AND INFORMATION SERVICES, THROUGH SPECIAL "PRODUCT WATCH": OBES SURG (2012) 22:1144-1205 O-085, "(B)(4)". ABSTRACT MENTIONED: "...516 RE-DO (88 % CONCERNING GB [GASTRIC BANDING])...LATE COMPLICATIONS HAVE A LESS INVASIVE SOLUTION: POUCH DILATION 5%, EROSION 1,8%,...ONE PT EXPERIENCED A POSTOPERATIVE LEAKAGE AND THE EROSION RATE IS 4%." ALTHOUGH THE MANUFACTURER OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    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