BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2739298 · Received September 7, 2012

    Report

    Report Number
    2024601-2012-00814
    Event Type
    Injury
    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
    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 INFO 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. EROSION, BAND SLIPPAGE, POUCH DILATATION, AND HEARTBURN 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 EROSION AS FOLLOWS: "AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT." "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. EROSION OF THE BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY AFTER THE USE OF GASTRIC-IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AND AFTER EXTENSIVE DISSECTION OR USE OF ELECTROCAUTERY, AND DURING EARLY EXPERIENCE." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE AND POUCH DILATATION 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 EVENT OF HEARTBURN AS FOLLOWS: "CAUTION: INSUFFICIENT WEIGH LOSS MAY BE A SYMPTOM OF INADEQUATE RESTRICTION (BAND TOO LOOSE), POUCH OR ESOPHAGEAL ENLARGEMENT, AND MAY BE ACCOMPANIED BY OTHER SYMPTOMS, SUCH AS HEARTBURN, REGURGITATION OR VOMITING. IF THIS IS THE CASE, INFLATION OF THE BAND WOULD NOT BE APPROPRIATE." "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

    ABSTRACT RECEIVED FROM ALLERGAN IRVINE, GLOBAL LITERATURE AND INFORMATION SERVICES, THROUGH SPECIAL "PRODUCT WATCH": OBES SURG (2012) 22:1144-1205 O-137 "(B)(4)". ABSTRACT MENTIONED: "THE GASTRIC BANDS WERE REMOVED DUE TO SLIPPAGE IN (B)(4) CASES ((B)(4)), INADEQUATE WEIGHT LOSS IN (B)(4) CASES ((B)(4)), EROSIONS IN (B)(4) CASES ((B)(4)), POUCH DILATATION IN (B)(4) CASES ((B)(4)) AND SEVERE INTRACTABLE HEARTBURN IN (B)(4) CASES ((B)(4)). THE MEAN INTERVAL FROM BAND PLACEMENT TO BAND REMOVAL WAS 62 MONTHS (RANGE 24-120 MONTHS). THE MAJORITY OF THE PTS ((B)(4)) WERE MANAGED IN THE ELECTIVE SETTING, WHILST (B)(4) PTS ((B)(4)) PRESENTED WITH ACUTE BAND-RELATED COMPLICATIONS AND REQUIRED URGENT INTERVENTION."

    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 Required Intervention