BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083537 · Received July 28, 2008

    Report

    Report Number
    9616099-2008-01870
    Event Type
    Injury
    Date Received
    July 28, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MUNWAR, S., ET AL (UNK). DELAYED EDGE DISSECTION ON PROXIMAL RCA AFTER STENT IMPLANTATION. ADD'L INFO HAS BEEN REQUESTED FROM THE AUTHOR AND WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. [SEE SCANNED PAGES.]

    Description of Event or Problem · 1

    A MAN WITH COMPLAINTS OF TYPICAL CHEST PAIN AND BREATHLESSNESS ON EXERTION FOR THE LAST 2 MONTHS, WAS ADMITTED FOR CORONARY ANGIOGRAM. THE PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION WAS STENTED WITH A 3.0X33MM CYPHER STENT AT 20 ATM. THE PT REMAINED VERY STABLE FOR 7 HOURS AFTER THE PROCEDURE. SUDDEN ONSET OF ACUTE LIFE THREATENING PROBLEMS CLEARLY INDICATED A SERIOUS PROBLEM. A DISSECTION AT THE PROXIMAL EDGE OF THE 1ST STENT EXTENDING TO THE OSTIUM OF THE RCA WAS NOTICED. ONCE PT WAS STABILIZED AND THE PROCEDURE REVIEWED, NO PROBLEM WAS FOUND NEAR THE PROXIMAL RCA IN THE FINAL CINE. IT IS UNCLEAR WHY THIS MAY HAVE HAPPENED 7 HOURS AFTER THE ORIGINAL PROCEDURE. THE RCA MAY HAVE GONE INTO SPASM, FROM STRESS OF SHEATH REMOVAL AS THE EVENT TOOK PLACE ONE HOUR AFTER THE SHEATH REMOVAL (PT ALSO EXPERIENCED SLIGHT VASO VAGAL EPISODE DURING FEMORAL COMPRESSION). FOUR MONTHS AFTER THE PROCEDURE, PT REMAINS ASYMPTOMATIC AND IS DOING ALL NORMAL PHYSICAL ACTIVITIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R