BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2810020 · Received October 23, 2012

    Report

    Report Number
    2024601-2012-01112
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    August 22, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. DEVICE ANALYSIS NOTED THAT THE BAND TUBING AND THE SHELL/RING OF THE BAND WERE BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT AND SURGICAL DAMAGE THAT OCCURRED DURING THE REMOVAL OF THE DEVICE. IN ADDITION, THE DEVICE ANALYSIS NOTED DISCOLORATION AND ACID DEGRADATION, SIGNS OF EROSION. THE DEVICE ANALYSIS ALSO NOTED THAT THE BUCKLE OF THE BAND WAS SEPARATED AND A SHARP BREAKAGE HAD BEEN NOTED. EROSION IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED. CAUTION: 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."

    Description of Event or Problem · 1

    RECEIVED A LAP-BAND SYSTEM IN THE ALLERGAN DEVICE ANALYSIS LABORATORY WITHOUT INFO. F/U FINDINGS: PFN (PRODUCT FIELD NOTE) RECEIVED STATES THE DEVICE WAS "REMOVED DUE TO STOMACH EROSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1666038

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention NONE REPORTED.