BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 764629 · Received September 21, 2006

    Report

    Report Number
    9616099-2006-01210
    Event Type
    Injury
    Date Received
    September 21, 2006
    Date of Event
    March 1, 2004
    Report Date
    September 21, 2006
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EIGHTEEN MONTHS AFTER STENT IMPLANTATION, A SECOND FOLLOW-UP CORONARY ANGIOGRAPHY AND IVUS DEMONSTRATED NO ANGIOGRAPHIC RESTENOSIS, BUT AN INCREASED IN THE AMOUNT OF THE NEO-INTIMAL TISSUE (NEO-INTIMAL VOLUME OF BOSTRUCTION IN-STENT OF 10%) AND VESSEL SIZE (VESSEL VOLUME=297.6 MM3 VS. 248.6 MM3 AT THE 6-MONTH POST PROCEDURE IVUS IMAGING), INDICATIVE PF POSITIVE REMOVELING (IN THE 12 MONTH PERIOD BETWEEN THE TWO IVUS EXAMINATIONS THERE WAS AN INCREASE OF 19.7% IN THE VESSEL VOLUME, FIG. 3). AT THAT TIME, THE PATIENT WAS ASYMPTOMATIC; AND NO FURTHER INVETERVENTION WAS PERFORMED. HE REMAINED FREE OF SYMPTOMS UNTIL MARCH 2004 (40 MONTHS AFTER THE BASELINE PROCEDURE), WHEN HE WAS ADMITTED TO THE HOSPITAL WITH AN INFERIOR MYOCARDIAL INFARCTION. ANGIOGRAPHY SHOWED STENT OCCLUSION (FIG 4A), AND IVUS IMAGING PERFORMED IMMEDIATELY AFTER GUIDEWIRE PASSAGE DEMONSTRATED MARKED POSITIVE VESSEL REMOVDELING WHEN COMPARED WITH THE 18TH MONTH POST-IMPLANTATION IVUS EXAMINATION (FIG. 4B AND C). BALLOON ANGIOPLASTY RESTORD VESSEL PATENCY, AND TWO BARE-METAL STENTS (DRIVER, MEDTRONIC) WERE IMPLANTED TO TREAT A CORONARY DISSECTION DISTAL TO THE PREVIOUS STENT WITH A VERY GOOD FINAL RESULT. PLEASE NOTE: THE DEVICE HEREIN REPORTED, 3.5X18MM CYPHER SIROLIMUS-ELUTING CORONARY STENT, HAS BEEN REPORTED WITH AN UNKNOWN CATALOG AND LOT NUMBER. THIS DEVICE WAS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT MIGHT BE SIMILAR TO THE UNITED STATES PRODUCT CXS18350. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS REPORT WAS RETRIEVED FROM THE CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS PUBLICATION 68:83-86 (2006) TITLE: VERY LATE THROMBOSIS AFTER DRUG-ELUTING STENTS. IN NOVEMBER 2000, THE PATIENT WAS ADMITTED TO OUR HOSPITAL WITH UNSTABLE ANGINA. A CORONARY ANGIOGRAM SHOWED A SIGNIFICANT LESION IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH A 3.5X18MM SIROLIMUS-ELUTING STENT (CYPHER; CORDIS, JOHNSON & JOHNSON) (FIG.1). THE PROCEDURE HAD A SATISFACTORY FINAL RESULT. THE PATIENT WAS DISCHARGE ONE DAY LATER WITHOUT IN-HOSPITAL COMPLICATIONS, AND WAS PRESCRIBED ASPIRIN (100MG/DAY) AND TICLOPIDINE (500MG BID). AFTER TWO MONTHS, TICLOPIDINE WAS DISCONTINUED; AND PATIENT WAS ADVISED TO STAY ON ASPIRIN INDEFINITELY. SIX MONTHS AFTER STENT IMPLANTATION, HE UNDERWENT FOLLOW-UP ANGIOGRAPHY AND IVUS IMAGING. QUANTITATIVE CORONARY ANGIOGRAPHY DEMONSTRATED AN ABSENCE OF INSTENT RESTENOSIS, AND IVUS REVEALED A MINIMAL AMOUNT OF INTIMAL HYPERPLASIA (NEO-INTIMAL VOLUME OF OBSTRUCTION IN-STENT OF 5%, FIG. 2).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R TICLOPIDINE