BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP SMALL W/ ACCESS PORT II

    MDR report key: 6148728 · Received December 6, 2016

    Report

    Report Number
    3006722112-2016-00378
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    August 17, 2016
    Report Date
    February 3, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO APOLLO AND A VISUAL EXAMINATION WAS PERFORMED ON THE DEVICE WHICH NOTED BLACK AND BROWN DISCOLORATION ON THE SHELL, RING AND BUCKLE OF THE DEVICE. WHITE FIBERS WERE OBSERVED ON THE OUTER SURFACE OF THE DEVICE. BROWN AND BLACK PARTICLES WERE OBSERVED ON THE OUTER SURFACE OF THE BAND. AN AIR LEAK TEST WAS PERFORMED AND LEAKAGE WAS OBSERVED. UNDER MICROSCOPIC ANALYSIS THE OPENING WAS NOTED TO BE UNIDENTIFIED ON THE SHELL/BELT JUNCTION. A NON-PENETRATING NICK WAS NOTED ON THE SHELL. MATERIAL DEGRADATION WAS OBSERVED ON THE RING, SHELL AND BELT. THE BAND TUBING WAS NOTED TO HAVE A STRIATED END CUT, CONSISTENT WITH DEVICE REMOVAL.

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER: DEVICE LABELING ADDRESSES THE REPORTED EVENT 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 NON-STEROIDAL 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. ADVERSE EVENTS: IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY. 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. WARNINGS: PATIENTS SHOULD BE ADVISED THAT THE LAP-BAND AP® SYSTEM IS A LONG-TERM IMPLANT. EXPLANT (REMOVAL) AND REPLACEMENT SURGERY MAY BE INDICATED AT ANY TIME. MEDICAL MANAGEMENT OF ADVERSE REACTIONS MAY INCLUDE EXPLANTATION. REVISION SURGERY FOR EXPLANTATION AND REPLACEMENT MAY ALSO BE INDICATED TO ACHIEVE PATIENT SATISFACTION.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "EROSION DETECTED ON EGD- BAND REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800127 LAP-BAND AP SMALL W/ ACCESS PORT II ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. B-20260 1456331

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention