BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1162746 · Received September 16, 2008

    Report

    Report Number
    3003742446-2008-00172
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 22, 2008
    Manufacturer
    CORDIS LLC
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MONTH POST IMPLANT, A FOLLOW-UP WAS MADE WITH ANGIOGRAM SHOWING THE RCA PT WITHOUT EVIDENCE OF SIGNIFICANT STENOSIS. FOURTEEN MONTHS POST IMPLANT ANOTHER FOLLOW UP ANGIOGRAM WAS MADE WHERE THE RCA WAS SEEN WIDELY PATENT, HOWEVER, THERE WAS MID AND DISTAL DISEASE SEEN IN THE RCA. PER PT: IN 2008 A SHARP, STABBING CHEST PAIN (INTERMITTENT IN NATURE) WAS EXPERIENCED. EMERGENCY CATHERIZATION AND ULTRASOUND WERE PERFORMED WHICH SHOWED THE STENT FRACTURED. THE PT WAS DISCHARGED TWO DAYS LATER. AN OUTPATIENT NUCLEAR STRESS TEST WAS DONE THE SAME DAY, WITH NEGATIVE RESULTS. THE PT WILL BE TREATED WITH UNSPECIFIED MEDICATIONS AND CARDIAC REHABILITATION. INTERMITTENT CHEST PAIN IS ONGOING. ALL AVAILABLE INFO WAS PROVIDED. THIS PRODUCT WILL NOT BE RETURNED FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED PT EXPERIENCED CHEST PAIN. THEREAFTER, TESTS WERE PERFORMED WHICH DEMONSTRATED A STENT FRACTURE. INVESTIGATION REVEALED THAT IN EARLY 2005, THE PT HAD A CYPHER STENT (30.5/33MM) IMPLANT AT 14 ATMOSPHERES IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH GOOD RESULTS. THERE WAS THROMBUS THROUGHOUT THE ENTIRE VESSEL AND LESION WAS PREDILATED. THERE IS NO DOCUMENTATION ON TORTUOSITY OR CALCIFICATION OF THE VESSEL AND/OR LESION. THE PT WAS TREATED FOR THE THROMBUS AND DISCHARGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization PERCOCET 5-325 EVERY 8 TO 12 HOURS AS NEEDED| WELCHOL 1250MG BID| BISOPROLOL 5MG DAILY| VITORIN 10-80 MG DAILY| PLAVIX-75 MG DAILY