BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2871737 · Received December 11, 2012

    Report

    Report Number
    2024601-2012-01261
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 5, 2008
    Report Date
    November 14, 2012
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2012. THE REPORTER DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. BASED UPON THE IMPLANT DATE AND BAND TYPE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POTENTIAL FOR BREAKAGE OR FAILURE AS FOLLOWS: "... THE LAP-BAND SYS IS NOT A LIFETIME PRODUCT AND IT MAY BREAK OR FAIL IN THE WHOLE OR IN PART, AT ANY TIME AFTER IMPLANTATION AND NOT WITHSTANDING THE ABSENCE OF ANY DEFECT." DEVICE LABELING ADDRESS THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." DEVICE LABELING ADDRESSES THE FOLLOWING CONCERNS TO PERFORMING AN ADJUSTMENT: "PRIOR TO DOING AN ADJUSTMENT TO DECREASE THE STOMA, REVIEW THE PT'S CHART FOR TOTAL BAND VOLUME AND RECENT ADJUSTMENTS. IF RECENT ADJUSTMENTS HAVE NOT BEEN EFFECTIVE IN INCREASING RESTRICTION AND THE PT HAS BEEN COMPLAINT WITH NUTRITIONAL GUIDELINES, THE PT MAY HAVE A LEAKING BAND SYSTEM, OR MAY HAVE POUCH ENLARGEMENT OR ESOPHAGEAL DILATATION DUE TO STOMAL OBSTRUCTION, BAND SLIPPAGE OR OVER-RESTRICTION."

    Description of Event or Problem · 1

    PT REPORTED THAT A FEW YEARS AGO, A LAP-BAND LEAK WAS NOTED DUE TO A BREAK IN TUBING. THE TUBING WAS EXPLANTED AND REPLACED. THE PT REPORTED FEELING NO RESTRICTION AFTER BEING HIT IN THE CHEST AND STOMACH BY A CAR DOOR. THE IMPLANTING PHYSICIAN INJECTED DYE INTO THE BAND AND PERFORMED AN X-RAY THAT SHOWED A LEAK AND BREAK IN THE TUBING. HEALTH PROFESSIONAL REPORTED THE SURGEON PERFORMED A "FLUOROSCOPY WITH CONTRAST" AND RESULTS SHOWED A LEAK. NO FLUID COULD BE FOUND. THE PORT AND TUBING WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI APOLLO ENDOSURGERY, INC. 10.0 CM 1412869

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR