BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AP LRG W/RAPIDPORT EZ

    MDR report key: 2192444 · Received July 26, 2011

    Report

    Report Number
    2024601-2011-00605
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND WAS DISCARDED AFTER SURGERY BY THE RPTR. THE RPTR WAS REQUESTED TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND PT DATA. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A RAPID PORT EZ STRAIN RELIEF. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. HEMATOMA IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER, EVENT DATE, IMPLANT DATE AND PT DATA HAS BEEN REQUESTED. THE SERIAL NUMBER REPORTED WAS FOR A BREAST IMPLANT AND NOT A B-20365, APL, RAPIDPORT EZ LAP-BAND SYSTEM. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CAUTION: 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." "ACCESS PORTS HAVE BEEN REPORTED TO BE "FLIPPED" OR INVERTED. IF YOU INITIALLY SEE AN OBLIQUE OR SIDE VIEW ON X-RAY, THEN EITHER REPOSITION THE PT OR THE X-RAY EQUIPMENT UNTIL YOU OBTAIN A PERPENDICULAR, OVERHEAD (0 DEGREE) VIEW. TARGETING THE PORT FOR NEEDLE PENETRATION CAN BE DIFFICULT IF THIS ORIENTATION IS NOT CONTROLLED." "CAUTION: THE ACCESS PORT MUST BE SECURELY FASTENED TO THE PT'S RECTUS FASCIA WITH ALL FOUR OF THE STAINLESS STEEL ANCHORS FIRMLY EMBEDDED IN THE PT'S FASCIA. IF THIS IS NOT ACHIEVED, THE ACCESS PORT MAY BECOME LOOSE AND INACCESSIBLE FOR POST-OPERATIVE ADJUSTMENTS, THUS REQUIRING REVISIONAL SURGERY." "WARNINGS: FAILURE TO SECURE THE BAND PROPERLY MAY RESULT IN ITS SUBSEQUENT DISPLACEMENT AND NECESSITATE REOPERATION." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF SURGICAL COMPLICATIONS AS FOLLOWS: "COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISK ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISK ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HEMATOMA AS FOLLOWS: "PERFORATION OF THE STOMACH CAN OCCUR. DEATH CAN ALSO OCCUR. SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND."

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS: THE ACCESS PORT WAS NOTED TO BE MOBILE DURING AN ADJUSTMENT AND THE PT WAS ADMITTED TO HOSPITAL. ALL FOUR STAPLES WERE NOTED TO BE DEPLOYED WHEN THE PORT WAS REMOVED. THE SURGEON NOTED THAT THE PT HAD A HEMATOMA AT THE PORT SITE A FEW WEEKS POST THE PRIMARY PROCEDURE. A NEW PORT WAS INSERTED AND SUTURED INSITU. THE RAPIDPORT EZ THAT WAS EXPLANTED WAS DISCARDED BY THE HOSPITAL AND IS NOT AVAILABLE FOR RETURN AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP LRG W/RAPIDPORT EZ LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R