BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2882596 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08228
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, DISSECTION IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A ECCENTRIC 99% STENOSED LESION IN THE MID CIRCUMFLEX ARTERY WITH HEAVY TORTUOSITY. PRE-DILATATION WAS PERFORMED AND THE 2.75 X 18 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. SOME RESISTANCE WAS NOTED WITH THE LESION. THE STENT WAS IMPLANTED; HOWEVER, A DISSECTION OCCURRED. A NEW XIENCE V STENT WAS USED TO TREAT THE DISSECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 2080141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention