BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3854283 · Received June 6, 2014

    Report

    Report Number
    2953200-2014-01146
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    January 16, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. THE ROLE OF PROCALCITONIN IN POSTIMPLANTATION SYNDROME AFTER EVAR: A PILOT STUDY. SARTIPY F, LINDSTRÖM D, GILLGREN P, TERNHAG A. (ANN VASC SURG. 2014 MAY;28(4):866-73). DOI: 10.1016/J.AVSG.2013.11.011. EPUB 2014 JAN 16. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: FEVER, INFECTION, ISCHEMIA, RENAL INFARCTION, STROKE, PNEUMONIA, RETROPERITONEAL HEMATOMA, INTENSE ABDOMINAL PAIN, DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THESE EVENTS. BACKGROUND: AFTER ENDOVASCULAR AORTIC REPAIR (EVAR) FOR TREATMENT OF AORTOILIAC ANEURYSMS, PATIENTS COMMONLY DEVELOP AN INFLAMMATORY REACTION: POSTIMPLANTATION SYNDROME (PIS). CLINICALLY, IT MAY BE HARD TO SEPARATE PIS FROM AN INFECTIOUS COMPLICATION. PROCALCITONIN (PCT) IS A DIAGNOSTIC MARKER FOR SEVERE BACTERIAL INFECTIONS AND SEPSIS. WE HYPOTHESIZE THAT LOW-PCT LEVELS FACILITATE THE PIS DIAGNOSIS AFTER EVAR. METHODS: SIXTY-NINE ELECTIVE EVAR PATIENTS WERE INCLUDED. TYMPANIC TEMPERATURE, C-REACTIVE PROTEIN (CRP), WHITE BLOOD CELL COUNT (WBC), AND PCT WERE MEASURED ON DAYS -1 AND +1, +3 AND +5. COMPLICATIONS, IN-HOSPITAL STAY, AND INFECTIONS WERE RECORDED. PIS WAS DEFINED BY A BODY TEMPERATURE OF =38°C AND WBC =12,000/¿L COMBINED WITH NO OTHER DETECTED COMPLICATION OR SURGICAL EVENT EXPLAINING THE INFLAMMATORY RESPONSE. THREE COHORT SUBGROUPS WERE COMPARED: THE NONCOMPLICATION GROUP, THOSE WITH PIS, AND THE PATIENTS WITH COMPLICATIONS OR ADDITIONAL OPEN SURGICAL EVENTS. RESULTS: ALL PATIENTS DEVELOPED VARIOUS EXTENTS OF POSTOPERATIVE INFLAMMATORY RESPONSES INCLUDING A RISE IN WBC, CRP, AND/OR TEMPERATURE. PIS WAS DIAGNOSED IN 12 PATIENTS. FORTY PATIENTS HAD NO COMPLICATION AND SEVENTEEN SUFFERED COMPLICATIONS OR HAD AN ADDITIONAL OPEN SURGICAL EVENT. ALL PIS PATIENTS SHOWED LOW-PCT LEVELS. ON DAY +3, IN THE PIS GROUP, MEDIAN PCT WAS 0.22 NG/ML (95% CONFIDENCE INTERVAL [CI]: 0.15-0.28), WBC 13.2 × 10(9)/L (11.4-15.6), AND CRP 196 MG/L (149-243). HIGH PCT WAS OBSERVED IN 6 PATIENTS, OUT OF WHICH 4 HAD COMPLICATIONS OR ADDITIONAL OPEN SURGICAL PROCEDURES. CONCLUSIONS: IN PATIENTS WITH PIS AFTER EVAR, THERE WAS A STRONG INFLAMMATORY REACTION. IN THE PIS CONDITION, PCT REMAINS LOW. THIS PILOT STUDY SHOWS THAT PCT MAY BE USEFUL FOR THE PIS DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333129 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R