BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 6138776 · Received December 1, 2016

    Report

    Report Number
    3006722112-2016-00310
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    July 12, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: A VISUAL EXAMINATION WAS PERFORMED ON THE RECEIVED LAP-BAND SYSTEM WITH ACCESS PORT I, TAPER II. THE BAND TUBING WAS NOTED TO BE SEPARATED FROM THE PORT TUBING. THE PORT SEPTUM AND A PORTION OF THE PORT TUBING WERE NOTED TO BE DISCOLORED, AND WERE BROWN IN APPEARANCE. NEEDLE MARKS WERE NOTED ON THE PORT SEPTUM. WHITE PARTICLES WERE NOTED ON THE OUTER SURFACE OF THE BAND SHELL AND RING. THE BAND SHELL AND RING WERE NOTED TO BE DISCOLORED, AND WERE SLIGHTLY YELLOW IN APPEARANCE. A FILL INSPECTION TEST WAS PERFORMED, AND NO BLOCKAGE WAS NOTED AS DI WATER WAS INJECTED INTO THE PORT SEPTUM, OR THROUGH THE OPENING OF THE TUBING. AN AIR LEAK TEST WAS PERFORMED, AND NO LEAKAGE WAS NOTED FROM THE BAND OR BAND TUBING. THE END OF THE BAND TUBING AND PORT TUBING WAS NOTED TO HAVE A STRIATED SURGICAL END CUT, CONSISTENT WITH REMOVAL OF THE DEVICE. A PORTION OF THE BUCKLE AND BUCKLE STRAP WERE NOTED TO BE MISSING. UNDER MICROSCOPIC ANALYSIS, THE EDGES WERE NOTED TO HAVE STRIATIONS.

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER: THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AND TO INDICATE PRODUCT SERIAL NUMBER. TO DATE, NEITHER THE DEVICE NOR ANY FURTHER DEVICE INFORMATION HAS BEEN RECEIVED BY APOLLO. WITHOUT DEVICE OR DEVICE SERIAL, THE TAPER TYPE IS UNKNOWN. IF RETURNED, VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: 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. ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION, AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES. 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. 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 GERD AND DYSPHAGIA FOR THE PAST YEAR. AN EGD DIAGNOSED THE PATIENT WITH A "DILATED POUCH." DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790226 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention