BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAB-BAND AP STANDARD WITH ACCESS PORT I

    MDR report key: 6149264 · Received December 6, 2016

    Report

    Report Number
    3006722112-2016-00382
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 10, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020183
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #1; MEDWATCH SENT TO FDA ON 05/11/2017. FURTHER REVIEW OF THIS RECORD NOTED THIS EVENT HAS BEEN REPORTED ON MDR 3006722112-2017-00007.

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER MEDWATCH SENT TO FDA ON 12/06/2016. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. TO DATE, APOLLO HAS NOT RECEIVED THE DEVICE. WITHOUT DEVICE, THE TAPER TYPE IS UNKNOWN. IF RETURNED, VISUAL EXAMINATION MAY CONFIRM OR DETERMINE THE TAPER TYPE ASSOCIATED WITH THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF "LEAK(S)" AS FOLLOWS: PRECAUTIONS: CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING THAT CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION. 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. DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTING TUBING. WARNINGS: PATIENTS SHOULD BE ADVISED THAT THE LAP-BAND AP® SYSTEM IS A LONG-TERM IMPLANT. EXPLANT 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.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM REPORTED "DURING LAP-BAND FILL, WHEN THE PHYSICIAN WAS ATTEMPTING TO PUSH FLUID THROUGH, THERE WAS A LEAK. THIS WAS DETERMINED BY THE PATIENT DRINKING LIQUID DURING THE FILL". THE PATIENT'S LAP-BAND SYSTEM REMAINS IMPLANTED AND THE SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798648 LAB-BAND AP STANDARD WITH ACCESS PORT I ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. B-2240 1716376 10811955020183

    Patients

    Seq Age Sex Outcome Treatment
    1