BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1200828 · Received October 17, 2008

    Report

    Report Number
    2024168-2008-00971
    Event Type
    Death
    Date Received
    October 17, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 19, 2008
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. DEATH, IS LISTED IN THE PROMUS INSTRUCTIONS FOR USE IS A KNOWN RISK ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PROD QUAL ISSUE. AS THERE WAS NO REPORTED DEVICE MALFUNCTION, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PROD QUALITY PROBLEM. IN THIS CASE, IT IS LIKELY THAT THE DEATH IS A SECONDARY EFFECT OF THE CARDIAC ARREST. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: CARDIAC ARREST REQUIRING MEDICAL INTERVENTION, SUBSEQUENTLY, THE PT EXPIRED. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PT PRESENTED WITH STEMI. THE PROMUS STENT WAS DEPLOYED IN THE CX. DURING THE PROCEDURE, THE LAD SHUT DOWN, ANGIOPLASTY WAS PERFORMED SUCCESSFULLY TO THE LAD; THE PT CODED DURING THE PROCEDURE AND WAS SHOCKED, THE RESULT OF THE PROCEDURE WAS SATISFACTORY. A WEEK LATER, THE PT PRESENTED TO A DIFFERENT HOSPITAL AND PASSED AWAY, CAUSE OF DEATH IS NOT KNOWN. NO ADD'L EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP 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 46 YR Death| R