BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP STANDARD W/ ACCESS PORT I

    MDR report key: 6136531 · Received November 30, 2016

    Report

    Report Number
    3006722112-2016-00364
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    September 21, 2016
    Report Date
    June 29, 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

    UNKNOWN TAPER, MEDWATCH SENT TO THE FDA ON 11/30/2016. 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. DEVICE LABELING ADDRESSES THE POSSIBLE EVENT OF DYSPHAGIA 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. 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

    TAPER I. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE APOLLO DEVICE ANALYSIS LABORATORY AND A VISUAL INSPECTION WAS PERFORMED ON THE RECEIVED LAP-BAND WITH ACCESS PORT I, TAPER I. THE LAP-BAND RING AND THE SHELL WERE NOTED TO BE DISCOLORED, BROWN IN COLOR. WHITE PARTICLES WERE NOTED ON THE OUTER SURFACE OF THE LAP-BAND SHELL. THE ACCESS PORT TUBING WAS NOTED TO BE DISCOLORED, ALSO BROWN IN COLOR. A PORTION OF THE BAND TUBING WAS STILL CONNECTED TO THE ACCESS PORT SS CONNECTOR. NEEDLE MARKS WERE NOTED ON THE PORT SEPTUM AND PORT HOLES. A FILL INSPECTION TEST WAS PERFORMED, AND NO BLOCKAGE WAS NOTED WHEN DI WATER WAS PASSED THROUGH THE PORT SEPTUM AND PORT TUBING. AN AIR LEAK TEST WAS PERFORMED, AND NO LEAKAGE WAS NOTED. THE END OF THE PORT TUBING AND BAND TUBING HAD STRIATIONS, CONSISTENT WITH A SURGICAL END CUT.

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #1: MEDWATCH SENT TO FDA ON 03/07/2017. ADDITIONAL INFORMATION: REPORT DATE, BRAND NAME, MODEL #/LOT #, DEVICE AVAILABLE FOR EVALUATION?, DATE RECEIVED BY MFR?, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, DEVICE MANUFACTURE DATE, EVALUATION CODES.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE DEVICE REMOVAL DUE TO "DYSPHAGIA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786520 LAP-BAND AP STANDARD W/ ACCESS PORT I ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. B-2240 1470371

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention