BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2139812 · Received June 24, 2011

    Report

    Report Number
    2024168-2011-04471
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. 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. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS A CONCENTRIC DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX), WITH MILD TORTUOSITY, NO CALCIFICATION, AND 99% STENOSIS. AFTER PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON, A 3.5 X 08 MM XIENCE V WAS DEPLOYED IN THE LCX. AFTER STENT PLACEMENT, PLAQUE SHIFT WAS NOTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). KISSING BALLOON TECHNIQUE (KBT) WAS ATTEMPTED TO TREAT THE PLAQUE SHIFT AND THE VOYAGER NC 3.5 X 15 MM WAS ADVANCED, BUT MET RESISTANCE WITH THE PREVIOUSLY DEPLOYED STENT STRUTS, AND IT WOULD NOT CROSS. A NON-ABBOTT BALLOON CROSSED AND KBT WAS SUCCESSFULLY COMPLETED TO TREAT THE PLAQUE SHIFT. NO ADVERSE PATIENT SEQUELAE WERE REPORTED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GUIDE WIRE: RUNTHROUGH, SIONGUIDE CATH: LAUNCHER