BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2220847 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05913
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. REPORTED DEVICE (B)(4): NO PRE-DILATATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION IS A KNOWN ADVERSE EVENT 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. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED VIA DIRECT STENTING, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER OF APPROPRIATE LENGTH AND DIAMETER. IN THIS CASE, THE REPORTED IFU DEVIATION DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS THAT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH SEVERE ANGINA. THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE DISTAL CIRCUMFLEX WITH HEAVY TORTUOSITY AND MODERATE CALCIFICATION. THE 2.75 X 23 MM XIENCE V STENT DELIVERY SYSTEM WAS ADVANCED FOR DIRECT-STENTING. THE STENT WAS IMPLANTED; HOWEVER, A PROXIMAL EDGE DISSECTION WAS NOTED, AND A 2.75 X 18 MM XIENCE V STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. 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-CT 1041341

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention GUIDE WIRE: BMW UNIVERSAL II