BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 6055977 · Received October 25, 2016

    Report

    Report Number
    3006722112-2016-00305
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    September 26, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER. MEDWATCH SENT TO THE FDA ON 10/25/2016. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AND TO INDICATE PRODUCT SERIAL NUMBER. TO DATE, NEITHER THE DEVICE NOR ANY FURTHER DEVICE INFORMATION HAS BEEN RECEIVED BY APOLLO. WITHOUT DEVICE OR DEVICE SERIAL, THE TAPER TYPE IS UNKNOWN. IF RETURNED, VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS EVENT. THIS EVENT WAS REPORTED BY THE PATIENT. APOLLO HAS BEEN UNABLE TO CONFIRM THE REPORTED EVENT OF PORT DISPLACEMENT WITH THE PATIENT'S PREVIOUS PHYSICIAN, HOWEVER THE OTHER REPORTED EVENTS HAVE BEEN CONFIRMED WITH THE PATIENT'S CURRENT PHYSICIAN. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: PRECAUTIONS: 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. FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE. IN ORDER TO AVOID INCORRECT PLACEMENT, THE PORT SHOULD BE PLACED LATERAL TO THE TROCAR OPENING. A POCKET MUST BE CREATED FOR THE PORT SO THAT IT IS PLACED FAR ENOUGH FROM THE TROCAR PATH TO AVOID ABRUPT KINKING OF THE TUBING. THE TUBING PATH SHOULD POINT IN THE DIRECTION OF THE ACCESS PORT CONNECTOR SO THAT THE TUBING WILL FORM A STRAIGHT LINE WITH A GENTLE ARCHING TRANSITION INTO THE ABDOMEN. ADVERSE EVENTS: IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. 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 PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY. ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION, AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, DEHYDRATION, GI PERFORATION, DIARRHEA, ABNORMAL STOOLS, CONSTIPATION, FLATULENCE, DYSPEPSIA, ERUCTATION, CARDIOSPASM, HEMATEMESIS, ASTHENIA, FEVER, CHEST PAIN, INCISION PAIN, CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA, PARESTHESIA, DYSMENORRHEA, HYPOCHROMIC ANEMIA, BAND LEAK, CHOLECYSTITIS, ESOPHAGEAL DYSMOTILITY, ESOPHAGEAL ULCER, ESOPHAGITIS, PORT DISPLACEMENT, PORT SITE PAIN, SPLEEN INJURY AND WOUND INFECTION

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "PORT-FLIPPED - REVISION DONE." PHYSICIAN REPORTED PATIENT EXPERIENCED "ESOPHAGEAL REFLUX AND PAIN." THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705450 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention BLOOD PRESSURE MEDICATIONS| INHALER-ALBUTEROL