BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083464 · Received July 23, 2008

    Report

    Report Number
    9616099-2008-01840
    Event Type
    Death
    Date Received
    July 23, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 25, 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 ELECTIVE CASE. THE TARGET LESION WAS THE MID LAD. THE LESION WAS REPORTED TO BE: DE NOVO, CONCENTRIC, A BIFURCATION LESION, 20 MM LENGTH, 3.0 MM VESSEL DIAMETER, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 2.0 X 15 MM BALLOON AT 8 ATM FOR 60 SEC. A CYPHER 2.5 X 23 MM STENT WAS IMPLANTED AT 16 ATM FOR 60 SEC. THE STENT WAS POST-DILATED WITH A 3.0 X 12 MM BALLOON AT 12 ATM FOR 60 SEC. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 2 AND POST-PROCEDURE TIMI 3. AN ACT OF 266 WAS 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 TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT # 9616099-2008-01839.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT APPROXIMATELY FORTY-MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN BUT DID NOT VISIT THE HOSPITAL. TWO DAYS LATER THE PATIENT WAS ADMITTED DUE TO WORSENING CHEST PAIN. THE PATIENT WAS SAID TO HAVE DEVELOPED LUNG CONGESTION AND AN ACUTE MYOCARDIAL INFARCTION WHILE IN THE HOSPITAL AND WENT INTO SHOCK. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED PROXIMAL AND IN THE PREVIOUSLY IMPLANTED CYPHER 2.5 X 23 MM STENT IN THE MID LEFT ANTERIOR DESCENDING TARGET LESION. ASPIRATION OF THE THROMBUS AND ANGIOPLASTY WERE DONE. AN ADDITIONAL CYPHER 3.0 X 28 MM STENT WAS IMPLANTED PROXIMAL TO THE OTHER CYPHER STENT IN OVERLAPPING FASHION. THE FLOW AFTER THE RE-PCI WAS SAID TO BE SUFFICIENT. THE PATIENT WENT ON TO DEVELOP RENAL AND HEPATIC FAILURE. DIALYSIS WAS STARTED SIX DAYS AFTER THE RE-PCI. THE PATIENT EXPIRED TWELVE DAYS AFTER THE RE-PCI DUE TO ATRIAL FIBRILLATION. AN AUTOPSY WAS NOT DONE. THE PHYSICIAN'S COMMENT REGARDING THE CAUSE OF THE VERY LATE THROMBOSIS WAS THAT THERE WAS A NEW STENOTIC LESION PROXIMAL AND PREVIOUSLY IMPLANTED STENT AND THAT THE CAUSE OF DEATH WAS ATRIAL FIBRILLATION.

    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 13367051

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| L| R