BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3130650 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03275
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 THROMBOSIS, DISSECTION, ANEMIA, ANGINA, AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS. 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). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ISCHEMIA, DISSECTION, THROMBOSIS, ANEMIA, ANGINA, AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS. 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

    IT WAS REPORTED THAT THE PATIENT HAD A MYOCARDIAL INFARCTION (MI) WITH CHEST PAIN, CHANGES IN THE ELECTROCARDIOGRAM, AND NEW ELEVATION IN CARDIAC BIOMARKERS DURING THE PROCEDURE. THROMBOLYTIC TREATMENT AND REOPRO WERE PROVIDED. DURING THE PROCEDURE THERE WAS A CORONARY ARTERY DISSECTION IN THE DISTAL LEFT CIRCUMFLEX CORONARY (LCX) ARTERY FROM WIRE DAMAGE THAT WAS TREATED SUCCESSFULLY WITH RAPID REWIRING OF THE LESION AND PROLONGED BALLOON DILATATION. THE PATIENT ALSO HAD ANEMIA, BUT NO TREATMENT WAS PROVIDED. THE MI AND DISSECTION RESOLVED THE SAME DAY. THERE WERE NO ADVERSE PATIENT SEQUELAE. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS A SLOW FLOW OR NO REFLOW PHENOMENON DURING THE PROCEDURE. THIS WAS AN ADDITIONAL DESCRIPTION OF THE THROMBOSIS EVENT THAT OCCURRED ON (B)(6) 2013 THAT WAS TREATED WITH REOPRO, RAPID REWIRING OF THE VESSEL, AND PROLONGED BALLOON DILATATION. THIS NO REFLOW PHENOMENON RESOLVED THE SAME DAY WITH NO ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232479 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R| S OTHER: ASPIRIN, PRASUGREL