BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1981916 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00762
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    July 16, 2010
    Report Date
    January 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. STENT: RX XIENCE V 2.5 X 28 MM (PART#1009539-28/LOT#9090141); RX XIENCE V: 2.75 X 28 MM (PART#1009540-28/LOT#9073141). THE RX XIENCE V 2.5 X 28MM (PART#1009539-28/LOT#9090141) IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE STENT REMAINS INSIDE THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF RESTENOSIS AND ANGINA AS LISTED IN THE PRODUCT 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 WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010 THE PATIENT UNDERWENT STENTING IN THE PRE-DILATED DISTAL RIGHT CORONARY ARTERY (RCA) WITH TWO 2.5 X 28 MM XIENCE V STENTS, AND IN THE PRE-DILATED MID RCA WITH ONE 2.75 X 28 MM XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN RESULTING IN A DIAGNOSTIC CORONARY ANGIOGRAM ON (B)(6) 2010 THAT FOUND 90% STENOSIS IN THE DISTAL RCA OF BOTH INDEX STENTS. THE LESION WAS TREATED WITH ANGIOPLASTY AND THE PATIENTS CONDITION RESOLVED. 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 9090141

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R