BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3113702 · Received May 10, 2013

    Report

    Report Number
    2024601-2013-00352
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF IT IS EXPLANTED IN THE FUTURE. THE DEVICE WAS REPOSITIONED AND REMAINS IMPLANTED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REPOSITIONED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. INTOLERANCE, POUCH DILATION, REFLUX AND OBSTRUCTION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF POUCH DILATATION AND OBSTRUCTION AS FOLLOWS: "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 BAND REPOSITIONING AND/OR REMOVAL. 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." "BAND DEFLATION MAY NOT RESOLVE THE DILATATION IF THE STOMA OBSTRUCTION IS DUE TO A SIGNIFICANT GASTRIC SLIPPAGE OR IF THE BAND IS INCORRECTLY PLACED AROUND THE ESOPHAGUS. BAND REPOSITIONING OR REMOVAL MAY BE NECESSARY IF BAND DEFLATION DOES NOT RESOLVE THE DILATATION." "ESOPHAGEAL DISTENSION OR DILATATION HAS BEEN REPORTED INFREQUENTLY. THIS IS MOST LIKELY A CONSEQUENCE OF INCORRECT BAND PLACEMENT, OVER-RESTRICTION, STOMA OBSTRUCTION, AND CAN ALSO BE DUE TO EXCESSIVE VOMITING, OR PT NONCOMPLIANCE, AND MAY BE MORE LIKELY IN CASES OF PRE-EXISTING ESOPHAGEAL DYSMOTILITY. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS. A REVISION PROCEDURE MAY BE NECESSARY TO RE-POSITION OR REMOVE THE BAND IF DEFLATION DOES NOT RESOLVE THE DILATATION. OBSTRUCTION OF STOMAS HAS BEEN REPORTED AS BOTH AN EARLY AND A LATE COMPLICATION OF THIS PROCEDURE. THIS CAN BE CAUSED BY EDEMA, FOOD, IMPROPER INITIAL CALIBRATION, BAND SLIPPAGE, POUCH TORSION, OR PT NON-COMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." "FLUID SHOULD BE REMOVED FROM THE SYSTEM IF THERE WERE SYMPTOMS OF EXCESSIVE RESTRICTION OR OBSTRUCTION, INCLUDING EXCESSIVE SENSE OF FULLNESS, HEARTBURN, REGURGITATION AND VOMITING. IF SYMPTOMS ARE NOT RELIEVED BY REMOVAL OF THE FLUID, A BARIUM MEAL SHOULD BE USED TO EVALUATE THE ANATOMY."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED, PT EXPERIENCED NIGHT REGURGITATION AND A BARIUM SWALLOW NOTED THE BAND WAS TIGHT AND IT WAS DEFILED. PT STILL NOT TOLERATING SOLIDS, LIQUIDS. THE BAND WAS REPOSITIONED AND REMAINS IMPLANTED. FOLLOW-UP FINDINGS: A POUCH DILATATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208816 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1822538

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention