BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 698637 · Received April 7, 2006

    Report

    Report Number
    3003742446-2006-00248
    Event Type
    Injury
    Date Received
    April 7, 2006
    Date of Event
    March 9, 2006
    Report Date
    April 7, 2006
    Manufacturer
    CORDIS LLC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS FEMALE PATIENT WITH A PAST HISTORY OF KNOWN CORONARY ARTERY DISEASE WAS ADMITTED OT THE HOSPITAL WITH A CHIEF COMPLAINT OF KNOWN LAD STENOSIS PER DIAGNOSTIC ANGIOGRAM (ONE DAY PRIOR) . THE PATIENT WAS CURRENTLY TAKING NO REPORTED MEDICATIONS. THE PATIENT WAS TAKEN ELECTIVELY TO THE CARDIAC CATH LAB, WHERE ANGIOGRAPHY REVEALED A DIFFUSE, LONG , CALCIFIED DE NOVE STENOSIS OF THE PROXIMAL TO MID LAD. A BOLUS OF 45.5MG UNITS OF ANGIOMAX WAS ADMINISTERED VIA IV. FOLLOWED BY A CONTINUOUS INFUSION @ 1.75 MG/KG/HR. A 7FR FL4 GUIDER AND A PT2 GUIDEWIRE WERE USED TO SUCCESFULLY ACCESS AND WIRE THE LAD. THERE WERE NO DIFFICULTIES IN ACCESSING OR WIRING THE VESSEL NOTED.THE PROXIMAL TO MID LAD LESION WAS PREDILATED WITH A 2.0X12MM MAVERICK BALLOON INFLATED TO 12 ATMS (X3). THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.0X15MM CUTTING BALLOON ; HOWEVER, IT WOULD NOT CROSS THE LESION SITE. A 3.0X15MM QUANTUM BALLOON WAS ADVANCED ACROSS THE LESION AND WAS INFLATED TO 16ATMS (X3) IVUS WAS PERFORMED. A 2.5X13MM STENT WAS DEPLOYED TOO WAS ADVANCED; HOWEVER, IT TOO WOULD NOT CROSS THE LESION SITE. THE STENT WAS WITHDRAWN BACK INTO THE GUIDING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS LLC NA 50106599

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R