BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1082298 · Received July 25, 2008

    Report

    Report Number
    3003742446-2008-00136
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED IN THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBERS ARE 3003742446-2008-00136 AND 3003742446-2008-00137. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM A LITERATURE REVIEW. THE PT WAS A MALE WITH A HISTORY OF DIABETES AND CORONARY ARTERY DISEASE. THE PT PRESENTED TO THE ER WITH SUDDEN-ONSET RETROSTERNAL CHEST PAIN AND ST ELEVATIONS IN THE ANTERIOR, LATERAL AND INFERIOR LEADS. HE HAD STOPPED TAKING HIS CLOPIDOGREL 5 DAYS PREVIOUSLY. ANGIOGRAPHY REVEALED STENT THROMBOSIS IN THE MID LAD AND MID RCA STENTS WITH A TIMI FLOW OF 0 DISTALLY IN BOTH VESSELS. AN EMERGENT PCI WAS PERFORMED IN BOTH LESIONS WITH A CYPHER 3.5 X 23MM STENT DEPLOYED IN THE LAD AND A CYPHER 3.5 X 18MM STENT DEPLOYED IN THE RCA. THE PT WAS DISCHARGED 3 DAYS LATER ON A DUAL ANTIPLATELET REGIMEN. FOUR MOS PREVIOUSLY, THE PT UNDERWENT AN ELECTIVE PCI TO TREAT A CHRONIC TOTAL OCCLUSION OF THE RCA AND AN 80% STENOSIS OF THE MID LAD AT THE BIFURCATION OF THE SECOND DIAGONAL BRANCH. INDICATION FOR THE PCI WAS TYPICAL EXERTIONAL ANGINA. THE MID RCA WAS PREDILATED WITH A 2MM BALLOON AND STENTED WITH A 3.5 X 33MM CYPHER. A CYPHER 3.5 X 8MM WAS IMPLANTED PROXIMAL TO THE FIRST, OVERLAPPING TO TREAT THE FULL LESION. THE STENT WERE OPTIMALLY EXPANDED (INFLATION PRESSURE OF 16 ATM). THE MID LAD WAS DIRECTLY STENTED WITH A 3.5 X 23MM CYPHER, DEPLOYED AT 16 ATM. FOLLOWING DEPLOYMENT, THE 2ND DIAGONAL BRANCH WAS COMPROMISED. THUS THE 2ND SIGNAL WAS WIRED THROUGH THE MID LAD AND ITS OSTIUM WAS DILATED WITH A 2.5MM BALLOON AT 8 ATM. RESULTS WERE SATISFACTORY WITH GOOD RUNOFF IN THE DISTAL LAD AND DIAGONAL VESSELS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention