BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961765 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00309
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2009
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: XIENCE V 3.0 X 15 MM (PART1009541-15/LOT#7110741/SERIAL#(B)(4)); XIENCE V 4.0 X 08 MM (PART#1009543-08/LOT#8051941/SERIAL#(B)(4)). THE XIENCE V 3.0 X 15 MM (PART1009541-15/LOT#7110741/SERIAL#(B)(4)); XIENCE V 4.0 X 08 MM (PART#1009543-08/LOT#8051941/SERIAL#(B)(4)) ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ADDITIONALLY, ANGINA, RESTENOSIS, ADDITIONAL NON-SURGICAL TREATMENT, AND HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT ((B)(4)) AS NO FAULT COMPLICATIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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) 2008, THE PATIENT UNDERWENT XIENCE V STENTING IN THE PROXIMAL CIRCUMFLEX ARTERY WITH ONE 3.5 X 15 MM AND ONE 3.0 X 15 MM AND IN THE LEFT MAIN CORONARY ARTERY DIRECT STENTING WITH ONE 4.0 X 8 MM. ON (B)(6) 2009, THE PATIENT EXPERIENCED CHEST PAIN THAT WAS UNRELIEVED BY SUBLINGUAL NITROGLYCERIN. ON (B)(6) 2009, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION OF BOTH INDEX TARGET LESIONS. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2009. 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 8052642

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R