BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM

    MDR report key: 2933152 · Received January 18, 2013

    Report

    Report Number
    2183959-2013-00309
    Event Type
    Death
    Date Received
    January 18, 2013
    Date of Event
    September 12, 2012
    Report Date
    January 8, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION PROVIDED FROM THE INITIAL REPORTER INDICATES THERE WERE NO PRODUCT RELATED COMPLICATIONS. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THERE IS NO INDICATION THAT THE DEVICE WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING SPECIFIC LOT/SERIAL NUMBERS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELEVATE APICAL AND POSTERIOR WAS IMPLANTED ON (B)(6) 2012 TO TREAT FOR PROLAPSE. IT WAS DESCRIBED AS A "MODEL PROCEDURE WITH EASY ACCESS TO THE RELEVANT ANATOMICAL SITES WITH GOOD VISUALIZATION WHERE NEEDED," TAKING THE TIME AS NEEDED AND "BLOOD LOSS WAS ALMOST NIL." ADDITIONAL INFORMATION RECEIVED INDICATES THAT TWO DAYS AFTER SURGERY THE PATIENT HAD DE NOVO (NEW ONSET) ATRIAL FIBRILLATION AND WAS STARTED ON ACENOCOUMAROL (ANTICOAGULANT) IN THE "STANDARD DOSAGE FOR HER AGE, ACCORDING TO PROTOCOL." WHEN AN OUTPATIENT SERVICE VISITED THE PATIENT'S HOME AND CHECKED HER INR (BLOOD CLOTTING TIME), IT WAS FOUND TO BE ELEVATED AT ">10," INDICATING INCREASED CLOTTING TIME. ON (B)(6) 2012 FIVE DAYS AFTER THE INITIAL SURGERY THE PATIENT RETURNED TO THE HOSPITAL BECAUSE OF PAIN AND "SOME BLOOD LOSS THAT WAS NOT CONSIDERED AS ABNORMAL." A HEMATOMA HAD FORMED BETWEEN THE VAGINA AND THE RECTUM. SHE HAD NO FEVER BUT CRP (C-REACTIVE PROTEIN) WAS ELEVATED AND LEUCOCYTES (WHITE BLOOD CELLS) WHERE INCREASED. ACTIONS TAKEN INCLUDED ANTIBIOTICS AND, "AFTER CORRECTION OF THE HEMOSTASIS (INR >10)," THE HEMATOMA WAS REMOVED. OPERATIVE FINDINGS INCLUDED "A ROUND 1.5 CM LESION WITH INDURATED MARGINS IN THE ANTERIOR RECTAL MUCOSA, 4 CM FROM THE ANAL RING." BECAUSE OF THAT, A DRAIN WAS LEFT IN THE VAGINAL/RECTAL SPACE AND WAS A DOUBLE-LOOP STOMA (COLOSTOMY) WAS MADE ON THE TRANSVERSE COLON. FIVE DAYS LATER ANOTHER LAPAROTOMY WAS PERFORMED TO DRAIN A PRE-SACRAL ABSCESS. THE PATIENT ALSO WAS TREATED FOR SEPSIS. IT WAS REPORTED THAT "SHE HAD NOT REGAINED CONSCIOUSNESS," DESPITE IMPROVING INFECTION PARAMETERS AND THAT TWO WEEKS LATER THE PATIENT DIED IN THE ICU. THE ATTENDING INTENSIVE CARE PHYSICIAN STATED THE CAUSE OF DEATH WAS "EXHAUSTION," IN WHICH HER CARDIAC CONDITION "PLAYED PROBABLY AN IMPORTANT ROLE." THERE WAS NO POSTMORTEM EXAMINATION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28307 ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| R