BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2904456 · Received January 9, 2013

    Report

    Report Number
    2024168-2013-00168
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    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). NO PRE-DILATATION. IN THIS CASE, THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE INSTRUCTS THE PHYSICIAN TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED EXPERIENCING SEVERE CHEST PAIN. ANGIOGRAPHY REVEALED AN 80-90 % STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). USING A RADIAL APPROACH, DIRECT STENTING WAS PERFORMED WITH THE 3.5 X 28 MM XIENCE V, AND POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT 3.5 X 12 MM BALLOON. FOLLOWING CINE REVEALED A DISSECTION AT THE DISTAL END OF THE STENT. A 3.5 X 15 MM XIENCE V STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11984 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2012741

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DILATATION CATHETER: 3.5X12MM NC SPRINTER