BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1973910 · Received January 31, 2011

    Report

    Report Number
    2024168-2011-00553
    Event Type
    Death
    Date Received
    January 31, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH, PERFORATION, HYPOTENSION, AND ARRHYTHMIA ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREDILATATION WAS PERFORMED PRIOR TO STENT DEPLOYMENT AND THAT AFTER STENT DEPLOYMENT, A PERFORATION WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) AND THE PATIENT WAS RUSHED TO SURGERY. DURING THE SURGICAL PROCEDURE, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREDILATATION WAS PERFORMED PRIOR TO STENT DEPLOYMENT AND THAT AFTER STENT DEPLOYMENT, A PERFORATION WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD), A 3.5 X 20 NON-ABBOTT BALLOON WAS USED TO CONTAIN THE PERFORATION AND THE PATIENT WAS RUSHED TO SURGERY. DURING THE SURGICAL PROCEDURE, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0070861

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death GUIDE WIRE: WHISPER, GUIDE CATHETER: J14| DILATATION CATHETER: 3.0 X 12 APEX