BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2003552 · Received February 23, 2011

    Report

    Report Number
    2024601-2011-00144
    Event Type
    Death
    Date Received
    February 23, 2011
    Date of Event
    June 6, 2007
    Report Date
    January 26, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). AN AUTOPSY WAS PERFORMED ON THE PT. TO THE BEST OF OUR KNOWLEDGE THE DEVICE REMAINED IMPLANTED. 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 WOULD HAVE DETERMINED THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. DEATH, STOMACH PERFORATION, INFECTION, AND DYSPNEA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DEATH AS FOLLOWS: "LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LAP-BAND SYSTEM IS MAJOR SURGERY AND DEATH CAN OCCUR. PRECAUTIONS: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF STOMACH PERFORATION AS FOLLOWS: DEVICE CAUTION: DO NOT PUSH THE TIP OF ANY INSTRUMENT AGAINST THE STOMACH WALL OR USE EXCESSIVE ELECTROCAUTERY. STOMACH PERFORATION OR DAMAGE MAY RESULT. STOMACH PERFORATION MAY RESULT IN PERITONITIS AND DEATH. "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DYSPNEA AS FOLLOWS: SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND.

    Description of Event or Problem · 1

    ARTICLE REPORT OF PT DEATH DUE TO SEPSIS THREE DAYS AFTER GASTRIC BANDING PROCEDURE. F/U INFO: DR EXONERATED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1387075

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death