BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2020837 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01782
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    November 24, 2009
    Report Date
    January 7, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. XIENCE STENTS: 3.0X18, 3.0X12, 2.75X12, 2.75X18, 2.5 X 15, 3.0 X 12. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, DISSECTION, AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V 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 OR DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IA A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS PATIENT EXPIRED ON (B)(6) 2011 AT HOME. THE PATIENT WAS NOT TAKEN TO THE HOSPITAL. THE DEATH CERTIFICATE INDICATES CARDIAC ARREST DUE TO ATHEROSCLEROTIC HEART DISEASE AS THE CAUSE OF DEATH WITH THE PATIENTS TOBACCO USE AS A SIGNIFICANT CONDITION CONTRIBUTING TO HIS DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE WITH XIENCE V STENTS, A DISTAL DISSECTION OCCURRED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH WAS TREATED WITH ANOTHER XIENCE V STENT. INCLUDING THE STENT TO TREAT THE DISSECTION, 8 XIENCE V STENTS WERE IMPLANTED, 2 IN THE CIRCUMFLEX, 4 IN THE LAD, ONE IN THE RIGHT POSTERIOR DESCENDING ARTERY AND ONE IN THE RIGHT CORONARY ARTERY. THROUGHOUT THE PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE EPISODES OF CHEST PAIN DURING BALLOON INFLATIONS THAT WAS TREATED WITH MEDICATION AND RESOLVED THE SAME DAY. ON (B)(6) 2009, THE PATIENT WAS FOUND TO HAVE ELEVATED CARDIAC ENZYMES. THERE WAS NO REPORTED INTERVENTION. THE EVENT RESOLVED THAT DAY AND THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THAT THE ENZYME ELEVATION WAS DETERMINED TO BE A PERIPROCEDURAL NON Q-WAVE MYOCARDIAL INFARCTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9080641

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| R| S