BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORNARY STENT

    MDR report key: 992506 · Received February 6, 2008

    Report

    Report Number
    9616099-2008-00280
    Event Type
    Death
    Date Received
    February 6, 2008
    Date of Event
    November 29, 2007
    Report Date
    January 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    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 EMERGENT CASE. TARGET LESION #1-1: THE TARGET LESION WAS THE PROXIMAL/MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS REPORTED TO BE; DE NOVO, A TOTAL OCCLUSION, DIFFUSELY DISEASED, 2.5 MM VESSEL DIAMETER, 50 MM LENGTH, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.0 X 20 MM BALLOON AT 6 ATM/30 SEC. A CYPHER 2.5 X 28 MM STENT (STENT #1) WAS IMPLANTED AT 12 ATM/30 SEC. AN ADDITIONAL CYPHER 2.5 X 23 MM STENT (STENT #2) WAS IMPLANTED AT 12 ATM/30 SEC PROXIMAL TO THE FIRST STENT IN OVERLAPPING FASHION. THE STENTS WERE POST-DILATED WITH A 2.5 X 25 MM BALLOON AT 16 ATM/15 SEC. IVUS WAS NOT DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 0 AND POST-PROCEDURE TIMI 3. TARGET LESION #1-2: THE TARGET LESION WAS THE PROXIMAL CIRCUMFLEX. THE LESION WAS REPORTED TO BE: DE NOVO, CONCENTRIC 2.5 MM VESSEL DIAMETER, 15 MM LENGTH, AND TYPE B1. THE LESION WAS PRE-DILATED WITH A 2.0 X 20 MM BALLOON AT 2 ATM/30 SEC. A CYPHER 2.5 X 18 MM STENT (STENT #3) WAS IMPLANTED AT 12 ATM/30 SEC. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORTS # 9616099-2008-00280, # 9616099-2008-00281, AND # 9616099-2008-00282.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THREE (3) DAYS AFTER THE INDEX PROCEDURE, THE PATIENT DIED SUDDENLY IN THE HOSPITAL. NO CORONARY ANGIOGRAPHY OR INTERVENTION WAS DONE. NO AUTOPSY WAS CONDUCTED. THE PATIENT HAD A TOTAL OF THREE (3) CYPHER STENTS IMPLANTED DURING THE INDEX PROCEDURE. THE PHYSICIAN'S COMMENT REGARDING THE POSSIBLE CAUSE OF DEATH IS THAT IT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORNARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13294828

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death 2.0 X 20 MM BALLOON| 2.5 X 25 MM BALLOON