BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3250026 · Received July 24, 2013

    Report

    Report Number
    2024601-2013-00612
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER I. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. EROSION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE DIAGNOSTIC TESTING, PT DATA OR FURTHER EVENT DETAILS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. EROSION OF THE BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY, AFTER THE USE OF GASTRIC IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AND AFTER EXTENSIVE DISSECTION OR USE OF ELECTRO-CAUTERY, AND DURING EARLY EXPERIENCE. SYMPTOMS OF BAND EROSION MAY INCLUDE REDUCED WEIGHT LOSS, WEIGHT GAIN, ACCESS PORT INFECTION, OR ABDOMINAL PAIN, RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED." "RE-OPERATION FOR BAND EROSIONS MAY RESULT IN A GASTRECTOMY OF THE AFFECTED AREA. ERODED BANDS HAVE BEEN REMOVED GASTROSCOPICALLY IN A VERY FEW CASES, DEPENDING ON THE DEGREE OF EROSION. CONSULTATION WITH OTHER EXPERIENCED LAP-BAND SYSTEM SURGEONS IS STRONGLY ADVISED IN THESE CASES."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS AN EROSION OF THE LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM AFTER AN EARLIER BANDED GASTRIC BYPASS. THE BAND WAS REMOVED BUT NOT REPLACED, A GASTRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346069 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1814766

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention