BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1869211 · Received October 1, 2010

    Report

    Report Number
    2024168-2010-02055
    Event Type
    Death
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MFR, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.5 X 23 MM PROMUS STENT WAS IMPLANTED. POST DILATATION WAS PERFORMED WITH A NON-ABBOTT DILATATION CATHETER. IVUS WAS PERFORMED AND THE PROCEDURE WAS ENDED. IT WAS REPORTED BY THE PT'S FAMILY THAT THE PT HAD EXPIRED ON (B)(6) 2010; HOWEVER, THE CAUSE OF DEATH IS UNK AT THIS TIME. NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death GUIDE CATH: TIGA 6F SL 3.5| DIL CATH: TAZUNA 20X15, BP 2.25X10| OTHER: IVUS (TERUMO)| GUIDE WIRE: RUNTHROUGH