BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 5055140 · Received September 3, 2015

    Report

    Report Number
    3006722112-2015-00339
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    July 14, 2015
    Report Date
    August 6, 2015
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER. MANUFACTURER RECEIVED A COPY OF MEDWATCH (B)(4) FROM THE USER FACILITY ON 08/06/2015. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. USER FACILITY STATED THE DEVICE IS AVAILABLE FOR ON-SITE EVALUATION ONLY, AND THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. DEVICE SERIAL AND CATALOG NUMBER WERE REQUESTED OF THE REPORTER, REPORTER STATED THEY ARE UNKNOWN. WITHOUT CATALOG OR SERIAL NUMBER, TAPER TYPE COULD NOT BE DETERMINED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: PRECAUTIONS: OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION. ANTI-INFLAMMATORY AGENTS, SUCH AS ASPIRIN AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), MAY IRRITATE THE STOMACH AND SHOULD BE USED WITH CAUTION. THE USE OF SUCH MEDICATIONS MAY BE ASSOCIATED WITH AN INCREASED RISK OF EROSION. INSUFFICIENT WEIGHT LOSS MAY BE CAUSED BY POUCH ENLARGEMENT OR, MORE INFREQUENTLY, BAND EROSION IN WHICH CASE FURTHER INFLATION OF THE BAND WOULD NOT BE. ADVERSE EVENTS: 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. SYMPTOMS OF BAND EROSION MAY INCLUDE REDUCED WEIGHT LOSS, WEIGHT GAIN, ACCESS PORT INFECTION, OR ABDOMINAL PAIN. REOPERATION TO REMOVE THE DEVICE IS REQUIRED. WARNING: ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT. CAUTION: DO NOT OVER-DISSECT THE OPENING. EXCESSIVE DISSECTION MAY RESULT IN MOVEMENT OR EROSION OF THE BAND.

    Description of Event or Problem · 1

    FIRST REPORTED BY USER FACILITY VIA FDA MW (B)(4) AS "LAP-BAND WAS REMOVED DUE TO EROSION OF THE BAND THAT RESULTED IN A STOMACH LEAK. DEVELOPED GASTROPARESIS POST LAP-BAND PLACEMENT." FOLLOW-UP WITH USER FACILITY CONFIRMED THE LAP-BAND WAS REMOVED DUE TO EROSION. ADDITIONAL INFORMATION FOUND THAT "UPON REMOVAL OF THE DEVICE A SMALL PERFORATION WAS NOTED, A REPAIR WAS PERFORMED WITH NO LEAK NOTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586661 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention