BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2842609 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07375
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    July 13, 2012
    Report Date
    October 31, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION IS LISTED IN THE ELECTRONIC XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. IT SHOULD BE NOTED THAT THE IFU STATES: DO NOT EXCEED RATED BURST PRESSURE (RBP) AS INDICATED ON PRODUCT LABEL. 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4): ABOVE THE RATED BURST PRESSURE. THE CUSTOMER REPORTED THE DEVICE REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THREE XIENCE V STENTS WERE IMPLANTED IN A DE NOVO, DISTAL-MID, RIGHT CORONARY ARTERY WITH DIRECT STENTINGS AT 20 ATMOSPHERES. APPROXIMATELY 43 MONTHS LATER, ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT'S TROPONIN LEVELS WERE ELEVATED AND THE ELECTROCARDIOGRAM INDICATED A NON-ST-ELEVATION MYOCARDIAL INFARCTION. A PERCUTANEOUS CORONARY INTERVENTION WAS DONE ON THE TARGET INDEX VESSEL, BUT NON-TARGET LESION AND COMPLETE REVASCULARIZATION WAS OBTAINED. THE SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2012. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 8062761

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R| S