BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP STANDARD W/ ACCESS PORT I

    MDR report key: 6138362 · Received December 1, 2016

    Report

    Report Number
    3006722112-2016-00366
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    October 14, 2016
    Report Date
    July 12, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY:A VISUAL EXAMINATION WAS PERFORMED ON THE RECEIVED LAP-BAND WITH ACCESS PORT I WITH, TAPER II. THE PORT TUBING WAS NOTED TO BE CUT FROM THE BAND TUBING WAS NOTED TO BE CUT FROM THE BAND TUBING. THE BAND TUBING WAS SEPARATED FROM BOTH THE BAND AND THE PORT. THE BAND WAS ALSO NOTED TO BE SEPARATED FROM THE BUCKLE. THE PORT SEPTUM AND A PORTION OF THE PORT TUBING WERE NOTED TO BE DISCOLORED, AND WERE BROWN IN APPEARANCE. NEEDLE MARKS WERE NOTED ON THE PORT SEPTUM. THE BAND SHELL AND THE BAND RING WERE NOTED TO BE DISCOLORED, AND WERE BROWN IN APPEARANCE. A FILL INSPECTION TEST WAS PERFORMED, AND NO BLOCKAGE WAS NOTED WHEN DI WATER WAS PASSED THROUGH THE PORT SEPTUM, OR THROUGH THE PORT TUBING. AN AIR LEAK TEST WAS PERFORMED, AND LEAKAGE WAS NOTED WHERE THE BUCKLE WAS SEPARATED FROM THE BAND SHELL/RING. THE END OF THE PORT TUBING AND ENDS OF THE BAND TUBING WERE BOTH NOTED TO BE STRIATED, CONSISTENT WITH DAMAGE FROM A SURGICAL TOOL. THE SEPARATED PIECE OF BAND TUBING MEASURED APPROXIMATELY 17 INCHES IN LENGTH. THE END OF THE SHELL/RING, WHERE THE BUCKLE WAS SEPARATED FROM THE BAND, WAS NOTED TO HAVE STRIATIONS, CONSISTENT WITH DAMAGE FROM A SURGICAL TOOL. THE ENDS OF THE BUCKLE/BUCKLE STRAP WERE ALSO NOTED TO BE STRIATED, CONSISTENT WITH DAMAGE FROM A REMOVAL TOOL.

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER. 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. FURTHER INFORMATION HAS BEEN REQUESTED OF THE INITIAL REPORTER REGARDING: EXPLANT DATE. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY APOLLO. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: 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. WARNINGS: PATIENTS SHOULD BE ADVISED THAT THE LAP-BAND AP® SYSTEM IS A LONG-TERM IMPLANT. EXPLANT (REMOVAL)AND REPLACEMENT SURGERY MAY BE INDICATED AT ANY TIME. MEDICAL MANAGEMENT OF ADVERSE REACTIONS MAY INCLUDE EXPLANTATION. REVISION SURGERY FOR EXPLANTATION AND REPLACEMENT MAY ALSO BE INDICATED TO ACHIEVE PATIENT SATISFACTION.

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #1: MEDWATCH SENT TO FDA ON 03/13/2017.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "COMPLICATIONS FROM BAND WITH EPIGASTRIC ABDOMINAL PAIN, DYSPHAGIA, GASTROESOPHAGEAL REFLUX DISEASE." DEVICE HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790362 LAP-BAND AP STANDARD W/ ACCESS PORT I ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. B-2240 1794863

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention