BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3180950 · Received June 20, 2013

    Report

    Report Number
    2024168-2013-03843
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, A XIENCE V STENT AND XIENCE PRIME STENT WERE IMPLANTED IN THE LEFT MAIN (LM) ARTERY AND A XIENCE V STENT WAS IMPLANTED IN A LEFT ANTERIOR DESCENDING (LAD) ARTERY. APPROXIMATELY, 14 MONTHS LATER, ON (B)(6) 2013, THE PATIENT HAD A CARDIO-RESPIRATORY ARREST, ADVANCED LIFE SUPPORT WAS GIVEN WITH MECHANICAL VENTILATION, HOSPITALIZED, AND THEN THE PATIENT EXPIRED ON (B)(6) 2013. THERE WAS NO AUTOPSY PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT ON (B)(6) 2013, THERE WAS AN ABNORMAL ELECTROCARDIOGRAM (ECG), CARDIOVASCULAR BETA-BLOCKER MEDICATIONS WERE GIVEN AS TREATMENT AND THE SYMPTOMS ARE LISTED AS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280442 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1022241

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death STENT: XIENCE PRIME 3.0X38, XIENCE V 3.5 X 15