BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2874866 · Received December 16, 2012

    Report

    Report Number
    2024168-2012-07985
    Event Type
    Death
    Date Received
    December 16, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH, HYPOTENSION AND PERFORATION ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. PREDILATATION WAS PERFORMED PRIOR TO STENTING WITH A NON-ABBOTT BALLOON. A 2.5X28 MM XIENCE PRIME STENT WAS DEPLOYED SUCCESSFULLY IN THE LESION AND POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. ON ANGIOGRAPHY THE VESSEL APPEARED OPEN; HOWEVER, HAZINESS WAS OBSERVED IN THE PROXIMAL END OF THE STENT, BUT BLOOD FLOW WAS SMOOTH. A PERFORATION WAS SUSPECTED AND THE PATIENT BEGAN EXPERIENCING A RAPID FALL OF BLOOD PRESSURE, SHORTNESS OF BREATH, AND CARDIAC ARREST. ATROPINE WAS ADMINISTERED AND PERICARDIOCENTESIS WAS PERFORMED; HOWEVER, WITH NO IMPROVEMENT AND THE PATIENT DIED WITHIN THE NEXT 30 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1081641

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death