BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3852008 · Received June 5, 2014

    Report

    Report Number
    2024168-2014-03611
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    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). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN POTENTIAL PATIENT EFFECT AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 99% STENOSIS, PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.0X12 MM BALLOON. A 2.75X28 MM RX XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE AND THE STENT WAS IMPLANTED. POST STENT DEPLOYMENT A PROXIMAL EDGE DISSECTION WAS NOTED. A 2.75X12 MM RX XIENCE PRIME STENT WAS IMPLANTED TO TREAT THE DISSECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329137 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3051641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention