BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2192403 · Received July 26, 2011

    Report

    Report Number
    2024601-2011-00600
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RPTR OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE PARTIAL IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. INFECTION, OBSTRUCTION AND INTOLERANCE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER, THE EXACT IMPLANT DATE AND PT DATA HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF OBSTRUCTION AS FOLLOWS: SERIOUS ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM FOR THE U.S. STUDY (RECORDED AS OF DECEMBER 2000, 299 PTS) TWENTY-SEVEN REVISION PROCEDURES, INVOLVING 26 SUBJECTS (9%, 26/299) OCCURRED. THESE WERE DUE TO 3 INITIALLY INCORRECT PLACEMENTS, 5 STOMA OBSTRUCTIONS OR BAND SLIPPAGE/POUCH DILATION. BAND SLIPPAGE/POUCH DILATATION AND/OR STOMA OBSTRUCTION WAS THE MOST COMMON ADVERSE EVENT ASSOCIATED WITH THESE EXPLANTS (32% - 24/75). "BAND DEFLATION MAY NOT RESOLVE THE DILATATION IF THE STOMA OBSTRUCTION IS DUE TO SIGNIFICANT GASTRIC SLIPPAGE OR IF THE BAND IS INCORRECTLY PLACED AROUND THE ESOPHAGUS. BAND REPOSITIONING OR REMOVAL MAY BE NECESSARY IF BAND DEFLATION DOES NOT RESOLVE THE DILATION." "OBSTRUCTION OF STOMAS HAS BEEN REPORTED AS BOTH AN EARLY AND A LATE COMPLICATION OF THIS PROCEDURE. THIS CAN BE CAUSED BY EDEMA, FOOD, IMPROPER INITIAL CALIBRATION, BAND SLIPPAGE, POUCH TORSION, OR PT NON-COMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "CAUTION: ESOPHAGEAL DISTENSION OR DILATATION HAS BEEN REPORTED TO RESULT FROM STOMA OBSTRUCTION DUE TO OVER-RESTRICTION, DUE TO EXCESSIVE BAND INFLATION. PTS SHOULD NOT EXPECT TO LOOSE WEIGHT AS FAST AS GASTRIC BYPASS PTS, AND BAND INFLATION SHOULD PROCEED IN SMALL INCREMENTS. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN 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." "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: INCISIONAL INFECTION, INFECTION, FEVER, ABNORMAL HEALING AND WOUND INFECTION." "SERIOUS ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM FOR THE U.S. STUDY (RECORDED AS OF DECEMBER 2000, 299 PTS) OTHER EVENTS ASSOCIATED WITH THESE EXPLANTS WERE INFECTION (4% - 3/75)." DEVICE LABELING ADDRESSES THE POTENTIAL OF ADVERSE EVENT AS FOLLOWS: "IT IS IMPORTANT TO DISCUSSED ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PT. COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS 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."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED ALLEGED OBSTRUCTION AND PUS. THE PROBLEM WAS FIRST NOTICED 2 DAYS AFTER IMPLANT SURGERY. THE PT WAS ADMITTED TO THE HOSPITAL WITH AN OBSTRUCTION. THE SURGEON REMOVED SALINE FROM THE DEVICE, BUT THE PT WAS UNABLE TO TOLERATE THE DIET. A CT SCAN AND UPPER GI WERE USED AND LOCATED, "PUS AROUND THE FOLD." THE DEVICE WAS REMOVED WITHOUT REPLACEMENT TWO MONTHS LATER.

    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 Hospitalization| R