BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG NON-US

    MDR report key: 1171107 · Received September 18, 2008

    Report

    Report Number
    2024601-2008-00711
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 18/SEP/08. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED ON THE REPORTED MODEL TYPE (VG) OF THE LAP-BAND SYSTEM, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. EROSION IS A SURGICAL/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."

    Description of Event or Problem · 1

    REPORTED AS: "A LADY PRESENTED TWO YEARS AFTER LAP-BAND SURGERY (LAGB VANGUARD, INAMED HEALTH, SANTA BARBARA,CA, USA) WITH HEMATEMESIS. SHE WAS STABLE ON ADMISSION AND BAND EROSION WAS DIAGNOSED ON GASTROSCOPY. LAPAROTOMY WAS PERFORMED TO REMOVE TO LAP BAND." FROM LITERATURE REVIEW: JOURNAL ARTICLE "LAP-BAND CAUSING LEFT GASTRIC ARTERY EROSION PRESENTING WITH TORRENTIAL HEMORRHAGE", KENG SIANG PNG, JAIDEEPRAJ RAO, KHONG HEE LIM, KOK HOONG CHIA, DEPARTMENT OF GENERAL SURGERY, TAN TOCK SENG HOSPITAL, SINGAPORE; PUBLISHED IN "OBES SURG 2008" SPRINGER SCIENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG NON-US DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention