BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2202064 · Received August 5, 2011

    Report

    Report Number
    2024601-2011-00617
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. EROSION IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED. CAUTION: AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THE REMOVAL OF A LAP-BAND SYSTEM DUE TO AN ALLEGED STOMACH EROSION. THE PROBLEM WAS FIRST NOTICED WHEN "THE PATIENT FELT A LOSS OF RESTRICTION." AN ESOPHAGOGASTRODUODENOSCOPY (EGD) TEST WAS PERFORMED DIAGNOSING THE EROSION BUT THE RESULTS ARE NOT AVAILABLE. THE ENTIRE SYSTEM WAS REMOVED AND NOT REPLACED. FOLLOW-UP FINDINGS: THE EXACT LOCATION OF THIS OBSERVATION IS UNKNOWN. THE SURGEON SAID IT WAS "A BAND EROSION." NO INFLAMMATION OR INFECTION WAS NOTED AT THE SITE OF EROSION. THE BAND ERODED INTO THE STOMACH AND THE STOMACH HAD TO BE MENDED, BUT THE PATIENT'S STOMACH "IS HEALING." THE SURGEON "WON'T PUT IN A NEW BAND" UNTIL THE PATIENT "IS COMPLETELY HEALED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1599271

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention NONE REPORTED.