BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3130766 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03292
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 17, 2010
    Report Date
    May 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. (B)(4) - INDICATION FOR USE. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. ANGINA, DYSPNEA, FATIGUE, ISCHEMIA, AND RESTENOSIS, AS LISTED IN THE XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IN THIS CASE, THE IFU DEVIATION DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE ADDITIONAL XIENCE V DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, TWO XIENCE V WERE IMPLANTED OVERLAPPING IN A RESTENOSED MID RIGHT CORONARY ARTERY (RCA) AND APPROXIMATELY 16 MONTHS LATER ON (B)(6) 2010, THERE WAS INFERIOR ISCHEMIA FOUND WITH TESTING. AN ANGIOGRAM FOUND MID RCA 99% IN-STENT RESTENOSIS AND ANGIOPLASTY WITH ANOTHER STENTING PROCEDURE WERE DONE ON (B)(6) 2010 IN THE MID RCA AS TREATMENT. THERE WAS 99% PRE-PROCEDURE STENOSIS AND 0% POST-PROCEDURE STENOSIS. THE SYMPTOMS RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2010. THERE WAS A REPORT OF ANGINA THAT RESOLVED WITH A NITROGLYCERINE PATCH. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2010. ON (B)(6) 2013, THE PATIENT COMPLAINED OF ANGINA, SHORTNESS OF BREATH (DYSPNEA) AND FATIGUE WHEN CLIMBED ONE FLIGHT OF STAIRS, A NUCLEAR STRESS TEST FOUND INFERIOR ISCHEMIA AGAIN AND ANOTHER PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS DONE ON (B)(6) 2013 ON THE TARGET LESION. THERE WAS NO DIAGNOSIS OF A MYOCARDIAL INFARCTION (MI). THE SYMPTOMS RESOLVED ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231214 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7111941

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R