BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904557 · Received November 22, 2010

    Report

    Report Number
    2024168-2010-02490
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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 VIA A TRIAL, THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2009. AFTER PREDILATATION OF THE LESIONS, ONE XIENCE V WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ONE XIENCE V STENT WAS PLACED IN THE DISTAL CIRCUMFLEX (CX). ON (B)(6) 2010, THE PATIENT WENT IN FOR A SCHEDULED APPOINTMENT AND HAD BEEN EXPERIENCING ILL-DEFINED SHARP CHEST PAIN, NON-EXERTIONAL, NOT RADIATING. THE PATIENT WAS REHOSPITALIZED AND UNDERWENT A REPEAT CATHETERIZATION ON (B)(6) 2010, DURING WHICH THE LAD TARGET LESION AND TARGET VESSEL WAS REVASCULARIZED WITH THE PLACEMENT OF A NON-ABBOTT STENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS 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 9050861

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R