BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2010633 · Received March 1, 2011

    Report

    Report Number
    2024601-2011-00121
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). 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. DEVICE LABELING ADDRESSES 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 PATIENT'S CHART FOR TOTAL BAND VOLUME AND RECENT ADJUSTMENTS. IF RECENT ADJUSTMENTS HAVE NOT BEEN EFFECTIVE IN INCREASING RESTRICTION AND THE PATIENT HAS BEEN COMPLIANT WITH NUTRITIONAL GUIDELINES, THE PATIENT MAY HAVE A LEAKING BAND SYSTEM, OR MAY HAVE POUCH ENLARGEMENT OR ESOPHAGEAL DILATATION DUE TO STOMAL OBSTRUCTION, BAND SLIPPAGE OR OVER-RESTRICTION." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF OBSTRUCTION AS FOLLOWS: "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 PATIENT NON-COMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "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 PATIENT 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 PATIENT NONCOMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "CAUTION: WHEN ADJUSTING BAND VOLUME IF FLUID HAS BEEN ADDED TO DECREASE THE STOMA SIZE, IT IS IMPORTANT TO ESTABLISH, BEFORE DISCHARGE, THAT THE STOMA IS NOT TOO SMALL. ... A PHYSICIAN FAMILIAR WITH THE ADJUSTMENT PROCEDURE MUST BE AVAILABLE FOR SEVERAL DAYS POST-ADJUSTMENT TO DEFLATE THE BAND IN CASE OF AN OBSTRUCTION." "CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PATIENT OF THE DIETARY RESTRICTIONS WHICH FOLLOW THIS PROCEDURE AND TO PROVIDE DIET AND BEHAVIOR MODIFICATION SUPPORT. FAILURE TO ADHERE TO THE DIETARY RESTRICTIONS MAY RESULT IN OBSTRUCTION AND/OR FAILURE TO LOSE WEIGHT." "CAUTION: PATIENTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PATIENTS WITH DENTURES MUST BE CAUTIONED TO BE PARTICULARLY CAREFUL TO CUT THEIR FOOD INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    SURGEON REPORTED THE EVENT AS "PATIENT CONSULTED FOR AN OBSTRUCTION, COULD NOT EAT FOOD. SURGERY WAS DONE AND THE LAP-BAND BROKE AT THE TUBING JUNCTION. THE DEVICE WAS REPLACED AS IT WAS BROKEN." THE APS LAP-BAND SYSTEM WILL BE RETURNED FOR EVALUATION. FOLLOW-UP FINDINGS: THE DEVICE WAS FOUND TO BE BROKEN WHEN THE SURGERY WAS STARTED. VISCOUS FLUID REMAINED IN THE BAND DUE TO THE BREAKAGE, WHICH CAUSED THE STOMAL OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1845190

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention