BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3221472 · Received July 9, 2013

    Report

    Report Number
    2024601-2013-00575
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ALLERGAN
    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

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4)2 013. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. 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. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE, POUCH DILATION, REFLUX AND VOMIT 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 EVENT OF BAND SLIPPAGE, POUCH DILATATION AND VOMITING 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 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 DILATION". DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VOMIT AND NAUSEA AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED." "NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE. FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION. DEFLATION OF THE BAND IS IMMEDIATELY INDICATED IN ALL OF THESE SITUATIONS. DEFLATION OF THE BAND MAY ALLEVIATE EXCESSIVELY RAPID WEIGHT LOSS AND NAUSEA AND VOMITING, OR RE-OPERATION TO REPOSITION OR REMOVE THE DEVICE MAY BE REQUIRED" DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF REFLUX AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, 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, "BARIUM SWALLOW CONFIRMS POUCH DILATATION (SLIP). PATIENT HAD ACID REFLUX, EPISODES OF VOMITING, REFLUX AT NIGHT AND NIGHT TIME REGURGITATION." THE BAND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313524 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1670754

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention