BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2739369 · Received September 7, 2012

    Report

    Report Number
    2024601-2012-00820
    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
    FR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. 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. BAND SLIPPAGE, INTOLERANCE, ESOPHAGEAL DILATATION, DISPLACEMENT, EROSION, AND INFECTION 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 BAND SLIPPAGE 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 SLIPPAGE MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INTOLERANCE AS FOLLOWS: "COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHOD UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE, AND THE PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ESOPHAGEAL DILATATION AS FOLLOWS: "ESOPHAGEAL DISTENSION OR DILATATION HAS BEEN REPORTED INFREQUENTLY. THIS IS MOST LIKELY A CONSEQUENCE OF INCORRECT BAND PLACEMENT, OVER-RESTRICTION, STOMA OBSTRUCTION, AND CAN ALSO BE DUE TO EXCESSIVE VOMITING, OR PT NON-COMPLIANCE, AND MAY BE MORE LIKELY IN CASES OF PRE-EXISTING ESOPHAGEAL DYSMOTILITY. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS. A REVISION PROCEDURE MAY BE NECESSARY TO RE-POSITION OR REMOVE THE BAND IF DEFLATION DOES NOT RESOLVE THE DILATION." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: CAUTION: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. FAILURE TO DO SO MAY RESULT IN THE INABILITY TO PERFORM PERCUTANEOUS BAND ADJUSTMENTS." 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 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."

    Description of Event or Problem · 1

    ABSTRACT RECEIVED FROM ALLERGAN IRVINE, GLOBAL LITERATURE AND INFO SERVICES, THROUGH SPECIAL "PRODUCT WATCH". OBES SURG (2012) 22:1144-1205 O-083, "(B)(4) STUDY", (B)(6)." ABSTRACT MENTIONED: "RESULTS: NO PERIOPERATIVE DEATH WAS REPORTED. OVERALL RATE OF COMPLICATIONS WAS (B)(4): 11 SLIPPAGES, 4 FOOD INTOLERANCES, 4 ESOPHAGEAL DILATATIONS, 2 INTRAGASTRIC MIGRATIONS, 14 PORT PROBLEMS (12 ROTATIONS ET 2 INFECTIONS)." ALTHOUGH THE MFR OF THE DEVICE IS UNK, 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 Required Intervention