BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3241247 · Received July 22, 2013

    Report

    Report Number
    2024168-2013-04594
    Event Type
    Death
    Date Received
    July 22, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED . THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT. 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. THE ADDITIONAL ADVERSE PATIENT EFFECTS ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT#.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT THE AIM OF THIS SUBSTUDY OF 1,178 PATIENTS OF THE SORT OUT IV TRIAL WAS TO COMPARE CLINICAL OUTCOMES AMONG PATIENTS WITH ACUTE CORONARY SYNDROMES (ACS) AND STABLE ANGINA PECTORIS (SAP) TREATED WITH EVEROLIMUS-ELUTING STENTS (EES) OR SIROLIMUS-ELUTING STENTS (SES). AT 18-MONTH FOLLOW-UP, PATIENTS WITH ACS HAD HIGHER RATES OF MACE COMPARED TO PATIENTS WITH SAP (8.1% VERSUS 6.7%; HR=1.23, 95% CI: 0.93-1.62). MACE DID NOT DIFFER SIGNIFICANTLY BETWEEN ACS PATIENTS TREATED WITH EES OR SES (7.3% VERSUS 8.9%; HR=0.81, 95% CI: 0.54-1.22) NOR BETWEEN SAP PATIENTS TREATED WITH EES OR SES (6.9% VERSUS 6.5%; HR=1.05, 95% CI: 0.71-1.55): 2.6% TOTAL LESION REVASCULARIZATION; 4.3% TOTAL VESSEL REVASCULARIZATION; 2.1% MYOCARDIAL INFARCTION; 2.4% STENT THROMBOSIS; 2.8% CARDIOVASCULAR DEATH; 4.5% ALL CAUSE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341352 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death STENT: PROMUS