BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2739428 · Received September 7, 2012

    Report

    Report Number
    2024601-2012-00821
    Event Type
    Death
    Date Received
    September 7, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: (B)(4) 2012. FOLLOW-UP WITH THE AUTHORS OF THE ABSTRACT IS NOT POSSIBLE SINCE NO CONTACT INFORMATION WAS PROVIDED; THEREFORE, WE WERE UNABLE TO REQUEST RETURN OF THE DEVICE. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. INFECTION, BAND SLIPPAGE, OBSTRUCTION, POUCH DILATATION, REFLUX, STOMACH PERFORATION, AND DEATH ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 EVENTS OF BAND SLIPPAGE, POUCH DILATATION, REFLUX, AND OBSTRUCTION AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED IF THERE IS TOTAL STOMA-OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION OR IF THERE IS ABDOMINAL PAIN." DEVICE LABELING ADDRESSES THE REPORTED EVENTS 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." "PERFORATION OF THE STOMACH CAN OCCUR. DEATH CAN ALSO OCCUR. 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    ABSTRACT RECEIVED FROM ALLERGAN IRVINE, GLOBAL LITERATURE AND INFORMATION SERVICES, THROUGH SPECIAL "PRODUCT WATCH": OBES SURG (2012) 22:1144-1205 O-086, "SYSTEMATIC REVIEW OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN PATIENTS WITH BODY MASS INDEX", (B)(6)HOSPITAL, (B)(6). ABSTRACT MENTIONED: "35 PATIENTS (6.8%) DEVELOPED COMPLICATIONS, INCLUDING WOUND INFECTION, BAND SLIPPAGE/MIGRATION, BAND OBSTRUCTION, GASTRIC POUCH DILATATION, GASTRO-ESOPHAGEAL REFLUX AND PORT LEAKAGE ON FOLLOW-UP. THERE WAS 1 DEATH ((B)(4)) AT 20 MONTHS POSTOPERATIVELY FROM SEPSIS FOLLOWING GASTRIC PERFORATION OF A DILATED GASTRIC POUCH." ALTHOUGH THE MANUFACTURER OF THE DEVICE IS UNKNOWN, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death| R