BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE CERTUS

    MDR report key: 3030212 · Received March 27, 2013

    Report

    Report Number
    8030904-2013-00007
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    October 28, 2011
    Report Date
    March 13, 2013
    Manufacturer
    ST. JUDE MEDICAL SYSTEMS AB
    Product Code
    DQX
    PMA / PMN Number
    K062769
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED; HOWEVER, WE DO NOT BELIEVE THE CAUSE OF THE DISSECTION WAS DUE TO DEVICE MALFUNCTION OR ANY DEFICIENCY WITH THE INSTRUCTIONS FOR USE REQUIRING CORRECTIVE ACTION. WE WILL CONTINUE TO CLOSELY MONITOR THE PERFORMANCES OF THIS PRODUCT FOR ANY SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    THE CASE HAPPENED ON (B)(6) 2011. (B)(6) FEMALE WAS ADMITTED WITH A STEMI AND TREATED ON THE CULPRIT LESION IN THE RCA ON (B)(6) (RESCUE PCI). SHE HAD SOME PATHOLOGY ON THE LAD AND CX, AND WAS EVALUATED WITH A NEW PROCEDURE ON (B)(6). FFR ON THE LAD SHOWED NONSIGNIFICANT DISEASE (0,87). WHEN TRYING TO PASS THE FFR-PRESSURE WIRE THROUGH THE ATHEROSCLEROTIC LESION IS CX, THERE WERE DIFFICULTIES. THE EXPERIENCED OPERATOR (DR (B)(6), WITH >1000PCIS) USED A BALLOON TO TRY TO STABILIZE THE DISTAL PART OF THE WIRE, TO NAVIGATE IN THE TORTUOUS CX. THEN A DISSECTION OCCURRED, CAUSING A SUBTOTAL OCCLUSION ON THE VESSEL. A PTGI WIRE WAS PLACED DISTAL IN THE RIGHT LUMEN, AND A TOTAL OF 3 DES WAS PLACED TO RECANALISE THE DISTAL PART OF THE VESSEL. A SMALLER POSTEROLATERAL BRANCH FROM THE CX OCCLUDED DUE TO THIS PROCEDURE. PT HAD CHEST PAIN, ENZYME RISE (CK-MB 90 MAXIMUM) - A PROCEDURE RELATED NEW INFARCTION PER DEFINITION, AND HAD TO STAY AN EXTRA NIGHT IN THE HOSPITAL DUE TO THIS COMPLICATION. THE LEFT VENTRICULAR FUNCTION WAS NORMAL AFTER BOTH PROCEDURES. OUR REPORTS LATER TELL US SHE IS SYMPTOM FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125021 PRESSUREWIRE CERTUS GUIDEWIRE SENSOR DQX ST. JUDE MEDICAL SYSTEMS AB 12006

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR