BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141809 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04514
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. RESTENOSIS IS 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, COULD NOT 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 APPROXIMATELY 32 MONTHS POST IMPLANTATION OF TWO XIENCE V STENTS, ONE IN THE PROXIMAL 1ST DIAGONAL ARTERY (P1ST DIAG) AND ONE IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD), THE PATIENT EXPERIENCED DYSPNEA ON EXERTION. AORTIC STENOSIS WAS DIAGNOSED AND ON (B)(6) 2011, THE AORTIC VALVE WAS REPLACED. ADDITIONALLY ON (B)(6) 2011, CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED IN THE TARGET VESSEL, BUT NON-TARGET LESION. THERE WAS NO ADVERSE SEQUELA REPORTED. ALTHOUGH REQUESTED, 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 8061161

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| S STENT: XIENCE V STENT 3.0 X 15MM