BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1222584 · Received November 5, 2008

    Report

    Report Number
    2024601-2008-00831
    Event Type
    Death
    Date Received
    November 5, 2008
    Date of Event
    November 15, 2001
    Report Date
    October 6, 2008
    Manufacturer
    BIOENTERICS CORP
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STRAIN RELIEF. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A STRAIN RELIEF. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT REC'D THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEATH, CANCER, AND DYSPHAGIA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DEATH AS FOLLOWS: "WARNINGS: LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LAP-BAND SYSTEM IS MAJOR SURGERY AND DEATH CAN OCCUR." DEVICE LABELING ADDRESSES POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE (CASE REPORT) FROM OTHER COUNTRY, "CARCINOMA OF ESOPHAGUS AFTER ADJUSTABLE GASTRIC BANDING" BY DR KYLIE L. SNOOK AND DR JAMES D. RITCHIE, KEYHOLE SURGERY CENTRE AND HOSPITAL, ANOTHER COUNTRY, PUBLISHED IN "OBESITY SURGERY, 13, 2003" 800-802, THROUGH FD-COMMUNICATIONS INC., REPORTED A SERIES OF EVENTS OVER A TIME FRAME OF 10 YEARS. THE REPORTED ALLEGED EVENTS ARE FOR THE SAME PT BUT WILL BE CAPTURED IN THREE FILES BASED ON THE DIFFERENT SERIAL NUMBERS OF THE DEVICES. THIS FILE WAS CREATED TO CAPTURE THE REPORTED ALLEGED EVENT(S) OF: "NOVEMBER 2001: "PATIENT DEVELOPED DYSPHAGIC SYMPTOMS....PARTIAL DEFLATION OF THE BAND: "DYSPHAGIA PERSISTED." THE FOLLOWING TEST WERE PERFORMED THROUGHOUT THE TWO YEARS TIME FRAME: "SUBSEQUENT BARIUM (MEAL) STUDY: "SHOWED NARROWING IN THE LOWER ESOPHAGUS, THOUGHT TO BE DUE TO SPASM AND PEPTIC ESOPHAGITIS." ENDOSCOPY: "REVEALED A FUNGATING LEISON ARISING FROM AN AREA OF BARRETT'S MUCOSA - LOWER ESOPHAGUS." BIOPSY: "REVEALED MODERATELY DIFFERENTIATED ADENOCARCINOMA" CT SCAN: "IDENTIFIED MULTIPLE LIVER METASTASES." SURGERY WAS PERFORMED: LAP-BAND SYSTEM REMOVAL AND STENT PLACEMENT "THE LAP-BAND WAS REMOVED VIA A LAPAROTOMY (BECAUSE OF DIFFICULT LAPAROSCOPIC ACCESS). ...A STENT WAS PLACED ACROSS THE OBSTRUCTING TUMOR." ...PALLATIVE CHEMOTHERAPY. ...PATIENT DEATH: LATE 2003."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R VOLTAREN 50 MG TID