BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1192110 · Received October 7, 2008

    Report

    Report Number
    9616099-2008-02397
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    July 10, 2007
    Report Date
    September 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED; ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES.) SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THREE YEARS POST IMPLANT; STENT THROMBOSIS AND RESTENOSIS WERE IDENTIFIED ON THE CYPHER STENT. THE REPORT RECEIVED INDICATED THAT THE TARGET LESION WAS THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND IT WAS AN IN STENT RESTENOSIS OF AN ML BARE METAL STENT. THE TARGET WAS A RESTENOTIC LESION PREVIOUS TREATED WITH TWO ML BARE METAL STENTS AND A BX VELOCITY STENT. ONE ML METAL STENT WAS IMPLANTED TO TREAT A DISSECTION CAUSED DURING A DIRECTIONAL CORONARY ATHERECTOMY. NINE MOS LATER, THE OSTIUM OF THE PROXIMAL RIGHT CORONARY RESTENOSED AND THE LESION WAS TREATED WITH A SECOND ML STENT, WHICH WAS IMPLANTED PROXIMAL TO THE FIRST ML STENT. APPROX THREE YEARS LATER, A TOTAL OCCLUSION AT THE DISTAL END OF THE DISTALLY IMPLANTED ML STENT WAS IDENTIFIED AND A 3.5X13MM BX VELOCITY STENT WAS IMPLANTED OVERLAPPING THE STENT. FOUR MOS POST BX VELOCITY IMPLANT, THE TARGET VESSEL PRESENTED WITH RESTENOSIS, WHICH WAS TREATED WITH ANGIOPLASTY; FIVE MOS LATER, THE TARGET PRESENTED RESTENOSIS AGAIN. THE RESTENOSIS IDENTIFIED WAS FOUND AT THE PROXIMAL AND DISTAL OF THE ML-STENTS, THERE WAS NO RESTENOSIS ON THE BX VELOCITY. THE RESTENOSIS WAS TREATED WITH A 3.5X18MM CYPHER STENT. THE OSTIAL LESION WAS CLASSIFIED AS TYPE B2. THE LESION WAS 15MM LONG WITH A 3.5MM REFERENCE VESSEL DIAMETER. THE CYPHER STENT WAS DEPLOYED AT 18 ATMOSPHERES (ATMS), POST STENTING THE LESION PRESENTED 0% RESIDUAL STENOSIS AND TIMI III FLOW. THREE YEARS LATER POST CYPHER STENT IMPLANT, THE PT COMPLAINED OF CHEST PAIN; THE PT WAS DIAGNOSED WITH UNSTABLE ANGINA PECTORIS. A CORONARY ANGIOGRAM WAS CONDUCTED AND THROMBUS AND IN STENT RESTENOSIS WERE OBSERVED IN THE CYPHER STENT. THEREFORE, TO TREAT THE THROMBUS AND THE RESTENOSIS, ASPIRATION AND BALLOON ANGIOPLASTY WERE CONDUCTED. AFTER THE TREATMENT FOR THE THROMBUS, THE VESSEL FLOW WAS RESTORED. FURTHER INFO INDICATED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE "LESION HAD REPEATEDLY RESTENOSED, UNDER-DILATATION OF THE CYPHER STENT AND THE PHYSICIAN STOPPED THE ADMINISTRATION OF APT."

    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 I0304065

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R HEPARIN| MEDICATIONS INCLUDE: ASPIRIN| TICLOPIDINE| HYDROCHLORIDE