BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1151429 · Received September 5, 2008

    Report

    Report Number
    2024168-2008-00771
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. PERFORATION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. PERFORATION, AS LISTED IN THE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND NOT NECESSARILY IN INDICATION OF A PRODUCT QUALITY ISSUE. DIFFICULTY TO DEPLOY CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, AND INFLATION TECHNIQUE WHEN USING THE DEVICE. NO INFO REGARDING THE PT ANATOMY WAS PROVIDED. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: PERFORATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: DIFFICULT TO DEPLOY STENT. IT WAS REPORTED THAT THE XIENCE V WAS DEPLOYED IN THE MID LAD AT 8 ATM AND THERE APPEARED TO BE A SLIGHT WAIST SO THE STENT DELIVERY BALLOON WAS THEN INFLATED TO 10 ATMS AND A PERFORATION RESULTED. A PERICARDIOCENTESIS WAS PERFORMED AND A GRAFTMASTER WAS USED TO SEAL THE PERFORATION SUCCESSFULLY. THE PT IS DOING WELL. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention