BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 1970076 · Received January 14, 2011

    Report

    Report Number
    2024601-2011-00001
    Event Type
    Death
    Date Received
    January 14, 2011
    Date of Event
    May 8, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. SINCE ALLERGAN HAS NOT YET RECEIVED THIS INFO THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. ALLERGAN HAS NO RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. STOMACH PERFORATION, INFECTION, IRRITATION/INFLAMMATION, PAIN, AND VOMIT 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 STOMACH PERFORATION AND DEATH AS FOLLOWS: 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 IRRITATION/INFLAMMATION AS FOLLOWS": "CONTRAINDICATION(S): THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: PATIENTS WITH INFLAMMATORY DISEASES OF THE GASTROINTESTINAL TRACT, INCLUDING SEVERE INTRACTABLE ESOPHAGITIS, GASTRIC ULCERATION, DUODENAL ULCERATION, OR SPECIFIC INFLAMMATION SUCH AS "CROHN'S DISEASE". DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION..." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VOMIT AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED".

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS "PT FELL ILL SIX WEEKS AFTER THE GASTRIC BANDING SURGERY. DURING THE FOLLOW UP VISIT [WHERE] A SURGEON REMOVED SOME FLUID FROM THE GASTRIC BAND IN A BID TO MAKE [THE PT] MORE COMFORTABLE AND THE PT RETURNED HOME. PT WAS THEN FOUND UNCONSCIOUS IN THE BATHROOM AND WAS RUSHED TO THE HOSPITAL WHERE THE PT NEVER REGAINED CONSCIOUSNESS AND A POST-MORTEM EXAMINATION SHOWED [THE PATIENT] DIED FROM GASTRIC PERITONITIS. IT WAS ALSO CONFIRMED THAT THE PERITONITIS WAS CAUSED BY A PERFORATED STOMACH LINING." FOLLOW-UP INFO: "THE SURGEON DOES NOT BELIEVE THAT THE DEVICE CAUSED THE DEATH; HOWEVER, HE DOES STATE THAT HAD [THE PATIENT] NOT HAD THE OPERATION IT IS UNLIKELY THAT [THE PATIENT] WOULD HAVE DIED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1804150

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| R