BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 982869 · Received January 22, 2008

    Report

    Report Number
    9616099-2008-00185
    Event Type
    Injury
    Date Received
    January 22, 2008
    Date of Event
    May 29, 2005
    Report Date
    December 25, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS REPORTED TO BE THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS REPORTED TO BE: AN ISR OF A PREVIOUSLY IMPLANTED 3.5 MM PALMAZ SCHATZ STENT (IMPLANTED IN 1997), CONCENTRIC, BIFURCATED, CALCIFIED, A FLEXION LESION, 40MM IN LENGTH, 3.2MM VESSEL DIAMETER, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 3.0 X 20MM BALLOON AT 12 ATM FOR 30 SEC. A CYPHER 3.0 X 23MM STENT (STENT #1) WAS IMPLANTED AT 14 ATM FOR 30 SEC. A CYPHER 3.5 X 23MM STENT WAS THEN IMPLANTED PROXIMALLY AT 14 ATM FOR 30 SEC IN OVERLAPPING FASHION. THE STENTS WERE NOT POST-DILATED. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 1 AND TIMI 3 POST-PROCEDURE. AN ACT WAS NOT MEASURED. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. MFG RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED FOR THE SAME PATIENT. PLEASE REFERENCE MFR. REPORT #9616099-2008-00184, #9616099-2008-00185, AND #1016427-2008-00019.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT APPROX THREE (3) MONTHS AFTER THE PATIENT'S INDEX PROCEDURE FOR CYPHER STENT IMPLANTATION, THE PATIENT HAD CHEST PAIN THAT LASTED FOR ONE DAY. THE PATIENT WAS TAKEN EMERGENTLY TO THE HOSPITAL. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS NOTED IN THE TWO (2) PREVIOUSLY IMPLANTED CYPHER STENTS. AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED. THE LATE THROMBOSIS (LT) WAS TREATED BY ASPIRATION OF THE THROMBUS AND ANGIOPLASTY USING A MAVERICK 3.0 X 20MM BALLOON. THE PATIENT WAS REPORTED TO HAVE RECOVERED AND WAS DISCHARGED SEVENTEEN DAYS AFTER ADMISSION. THE PHYSICIAN'S COMMENT REGARDING THE POSSIBLE CAUSE OF THE LT WAS THAT THE PATIENT WAS ON DIALYSIS AND THE LESION WAS AN IN STENT RESTENOSIS (ISR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0105040

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 3.0 X 20 MM BALLOON