BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2761313 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06085
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 4, 2012
    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). GUIDE WIRE: BMW; INFLATION: MEDTRONIC; GUIDE CATH: CORDIS; SHEATH: CORDIS. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED, 90% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATATION WITH A 2.0 X 12 MM VOYAGER BALLOON CATHETER, A 2.5 X 28 MM XIENCE V STENT WAS IMPLANTED. THERE WAS A DISSECTION AT THE PROXIMAL EDGE OF THE IMPLANTED STENT, SO A SECOND 2.75 X 12 MM XIENCE V WAS DEPLOYED TO COVER THE DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO 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 2022141

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention CONCOMITANT MEDICAL DEVICES