BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP STANDARD WITH RAPIDPORT EZ

    MDR report key: 5105306 · Received September 25, 2015

    Report

    Report Number
    3006722112-2015-00389
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 27, 2015
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER. THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WILL NOT BE RETURNED. FURTHER INFORMATION REGARDING IMPLANT DATE AND DEVICE SERIAL NUMBER HAS BEEN REQUESTED OF THE IMPLANTING PHYSICIAN. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY APOLLO. WITHOUT SERIAL, CATALOG, OR MODEL NUMBER, THE TAPER TYPE ASSOCIATED WITH THIS EVENT CANNOT BE DETERMINED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF BAND SLIP AS FOLLOWS: WARNING: OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION. ADVERSE EVENTS: BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE SURGERY TO REPOSITION AND/OR REMOVE THE BAND. IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED IF THERE IS TOTAL STOMA-OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION OR IF THERE IS ABDOMINAL PAIN. 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. CAUTION: PATIENTS SHOULD BE ADVISED THAT THE LAPBAND® SYSTEM IS A LONG-TERM IMPLANT. EXPLANT 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.

    Additional Manufacturer Narrative · 1

    RAPIDPORT EZ STRAIN RELIEF. SUPPLEMENT # 1 - MEDWATCH SENT TO FDA ON: 11/02/2015. BASED ON THE SERIAL NUMBER PROVIDED, IT IS ASSUMED THIS DEVICE'S ACCESS PORT CONFIGURATION IS A RAPIDPORT EZ STRAIN RELIEF.

    Description of Event or Problem · 1

    REPORTED AS: THE PATIENT ARRIVED AT THE ER VERY MALNOURISHED, THIN, AND DEHYDRATED. PATIENT HAD A GASTRIC PROLAPSE AND GASTRIC OBSTRUCTION. PATIENT HAD THE ENTIRE LAP-BAND SYSTEM EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634427 LAP-BAND AP STANDARD WITH RAPIDPORT EZ ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. AP STANDARD 2153326

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention