BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿

    MDR report key: 5100246 · Received September 24, 2015

    Report

    Report Number
    3008452825-2015-00078
    Event Type
    Injury
    Date Received
    September 24, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DXO
    PMA / PMN Number
    K131452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4). THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) STATES THAT VESSEL DISSECTION IS A POTENTIAL COMPLICATION WHICH MAY BE ENCOUNTERED DURING ALL CATHETERIZATION PROCEDURES.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE INTERNATIONAL JOURNAL OF CARDIOLOGY IN A LETTER TO THE EDITOR ON 5 OCTOBER 2014: "A PRESHAPED PRESSURE WIRE (AERIS, ST JUDE MEDICAL, ST PAUL, MN, USA) WAS ADVANCED TO THE DISTAL RCA WITH SLIGHT RESISTANCE ENCOUNTERED AT THE SITE OF THE MOST DISTAL LESION (FIG. 1B) AND HYPEREMIA WAS INDUCED WITH A PERIPHERAL INFUSION OF ADENOSINE AT 140 G/KG/MIN. FFR WAS 0.96 IN THE DISTAL VESSEL, INDICATING NO SIGNIFICANT FLOW LIMITATION. THE WIRE WAS WITHDRAWN TO THE CATHETER OSTIUM WHERE THE ABSENCE OF DRIFT WAS CONFIRMED IN AN OTHERWISE UNCOMPLICATED PROCEDURE. FINAL CHECK ANGIOGRAPHY REVEALED HOWEVER, A DISTINCT, ASYMPTOMATIC, BUT PERSISTENT DISSECTION FLAP AT THE SITE OF THE DISTAL RCA LESION (FIG. 1C INSET) THIS WAS THEREFORE STENTED WITH A 3.5 נ9 MM BARE METAL STENT (INTEGRITY, MEDTRONIC, MINNEAPOLIS, MN, USA) WITH A GOOD FINAL RESULT (FIG. 1D). HIGH-SENSITIVITY TROPONIN T PEAKED AT 46 NG/L, LEFT VENTRICULAR CONTRACTILITY REMAINED NORMAL, AND THE PATIENT WAS DISCHARGED AND REMAINS WELL." (DOI: (B)(4) /© 2014 ELSEVIER IRELAND LTD.)

    Description of Event or Problem · 1

    CORONARY ANGIOGRAPHY VIA THE RIGHT RADIAL ARTERY REVEALED MINOR DISEASE IN ALL MAJOR CORONARY VESSELS EXCEPT THE RIGHT CORONARY ARTERY, WHICH APPEARED DIFFUSELY DISEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631873 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO ST. JUDE MEDICAL, COSTA RICA LTDA CVD0063

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention