BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001951 · Received February 27, 2011

    Report

    Report Number
    2024168-2011-01234
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS INSTANCE, THE FAILURE TO CROSS AND RESISTANCE FELT IS LIKELY DUE TO INTERACTION WITH THE PREVIOUSLY IMPLANTED STENT. THEN, DURING WITHDRAWAL OF THE STENT DELIVERY SYSTEM THROUGH THE GUIDING CATHETER, THE PROXIMAL STENT STRUTS BECAME DAMAGED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION AND INTRA-VASCULAR ULTRASOUND (IVUS) WERE PERFORMED. A 2.5 X 28 MM AND A 3.0 X 28 MM PROMUS WERE IMPLANTED IN THE POSTERIOR DESCENDING ARTERY OR ATRIOVENTRICULAR BRANCH. THEN, AN ATTEMPT WAS MADE TO IMPLANT A PROMUS 3.5 X 28 MM; HOWEVER, THE DISTAL TIP OF THE DEVICE WAS EXPERIENCING RESISTANCE WITH THE IMPLANTED 3.0 X 28 MM PROMUS STENT. DURING REMOVAL THE 3.5 X 28 MM PROMUS STENT ENCOUNTERED RESISTANCE WITH THE GUIDE CATHETER, BUT WAS ABLE TO BE REMOVED. IT WAS THEN NOTED THAT THE PROXIMAL PART OF THE STENT WAS FLARED. ANOTHER PROMUS STENT WAS IMPLANTED, COMPLETING THE PROCEDURE. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0090161

    Patients

    Seq Age Sex Outcome Treatment
    1