BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2192426 · Received July 26, 2011

    Report

    Report Number
    2024601-2011-00602
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. EROSION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "CAUTION: THE BAND SHOULD NOT BE SUTURED TO THE STOMACH. SUTURING THE BAND DIRECTLY TO THE STOMACH MAY RESULT IN EROSION." "CAUTION: 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." "CAUTION: IN REVISION PROCEDURES, THE EXISTING STAPLE LINE MAY NEED TO BE PARTIALLY DISRUPTED TO AVOID HAVING A SECOND POINT OF OBSTRUCTION BELOW THE BAND. AS WITH ANY REVISION PROCEDURE, THE POSSIBILITY OF COMPLICATIONS SUCH AS EROSION AND INFECTION IS INCREASED. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN PERITONITIS AND DEATH, OR IN LATE EROSION OF THE DEVICE INTO THE GI TRACT." "CAUTION: OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "CAUTION: ANTI-INFLAMMATORY AGENTS, WHICH MAY IRRITATE THE STOMACH, SUCH AS ASPIRIN AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, SHOULD BE USED WITH CAUTION. THE USE OF SUCH MEDICATIONS MAY BE ASSOCIATED WITH AN INCREASED RISK OF EROSION." "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE CAUSED BY POUCH ENLARGEMENT OR MORE INFREQUENTLY BAND EROSION, IN WHICH CASE FURTHER INFLATION OF THE BAND WOULD NOT BE APPROPRIATE." ADVERSE EVENTS: "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 ELECTRO-CAUTERY, AND DURING EARLY EXPERIENCE. SYMPTOMS OF BAND EROSION MAY INCLUDE REDUCED WEIGHT LOSS, WEIGHT GAIN, ACCESS PORT INFECTION, OR ABDOMINAL PAIN. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED." "RE-OPERATION FOR BAND EROSIONS MAY RESULT IN A GASTRECTOMY OF THE AFFECTED AREA. ERODED BANDS HAVE BEEN REMOVED GASTROSCOPICALLY IN A VERY FEW CASES, DEPENDING ON THE DEGREE OF EROSION. CONSULTATION WITH OTHER EXPERIENCED LAP-BAND SYSTEM SURGEONS IS STRONGLY ADVISED IN THESE CASES." "SERIOUS ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM FOR THE US STUDY (RECORDED AS OF DECEMBER 2000, 299 PATIENTS) SEVENTY-FIVE SUBJECTS HAD THEIR ENTIRE LAP-BAND SYSTEMS EXPLANTED. OTHER EVENTS ASSOCIATED WITH THESE EXPLANTS WERE EROSION (5% - 4/75), INFECTION (4% - 3/75)."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED ALLEGED "EROSION." THE DEVICE HAS BEEN REMOVED WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1681272

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention