BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053424 · Received May 27, 2008

    Report

    Report Number
    3003742446-2008-00089
    Event Type
    Death
    Date Received
    May 27, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 29, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT THE PT HAD A NON-Q WAVE MYOCARDIAL INFARCTION (MI) APPROX TWENTY-FOUR HRS AFTER THE INDEX CAROTID STENTING PROCEDURE. THE PT'S POST-PROCEDURE CARDIAC ENZYMES WERE ELEVATED PRIOR TO DISCHARGE. THE PT WAS DISCHARGED FOUR DAYS AFTER THE PROCEDURE. THE MI WAS REPORTED AS UNRELATED TO BOTH THE INDEX PROCEDURE AND THE CORDIS PRODUCTS. THE TARGET LESION FOR THE PROCEDURE WAS THE DISTAL COMMON CAROTID ARTERY. THE PT WAS SYMPTOMATIC. THE LESION WAS REPORTED TO BE A 70% STENOTIC, 15 MM IN LENGTH, MODERATELY TORTUOUS, AND ECCENTRIC/ULCERATED. THE LESION WAS PRE-DILATED. AN ANGIOGUARD DEVICE WAS USED. A PRECISE 8X30MM STENT WAS IMPLANTED WITHOUT MY PROCEDURAL COMPLICATION OR DEVICE DEVIATION REPORTED. A REPORT OF AN ADDITIONAL ADVERSE EVENT WAS REC'D. APPROXIMATELY THREE WEEKS AFTER THE CAROTID STENT IMPLANTATION, THE PT WAS RE-ADMITTED WITH AN ACUTE MYOCARDIAL INFARCTION. THE PT WAS FOUND TO HAVE THROMBOSED A PREVIOUSLY IMPLANTED UNKNOWN CYPHER STENT IN THE CIRCUMFLEX CORONARY ARTERY. ATTEMPTS AT RE-INTERVENTION AND RESUSCITATION WERE NOT SUCCESSFUL AND THE PT EXPIRED. THE PATIENT IS A MALE WITH A MEDICAL HISTORY OF: HYPERLIPIDEMIA, PREVIOUS CORONARY BYPASS GRAFT SURGERY (CABG), CURRENT SMOKING (>5PACKS/DAY), DIABETES MELLITUS, CORONARY ARTERY DISEASE (CAD), PREVIOUS PERCUTANEOUS CORONARY INTERVENTION (PCI), AND HYPERTENSION. HIGH RISK CRITERIA FOR THE CAROTID PROCEDURE INCLUDED: CONTRALATERAL CAROTID OCCLUSION. THE PT'S MEDICAL HISTORY/RISK FACTORS OF PREVIOUS PCI/CABG, DIABETES AND SMOKING PUT HIM AT INCREASED RISK FOR MACE. THE PRODUCTS REMAIN IMPLANTED IN THE PT AND ARE THUS UNAVAILABLE FOR EVAL. FOR THE PRECISE STENT, MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. FOR THE UNKNOWN CYPHER STENT, MANUFACTURING RECORDS (DHR) COULD NOT BE REVIEWED, AS THE PRODUCT CATALOG AND LOT NUMBER ARE NOT AVAILABLE. STENT THROMBOSIS AND MYOCARDIAL INFARCTION ARE WELL-KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. BASED ON THE INFO AVAILABLE, PATIENT FACTORS (DIABETES, CURRENT SMOKER >5 PACKS/DAY) MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS OF STENT THROMBOSIS AND MYOCARDIAL INFARCTION. THIS IS ONE OF TWO PRODUCTS USED FOR THE SAME PT. PLEASE REFERENCE MFR REPORT #9616099-2008-01133 AND #3003742446-2008-00089. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT FROM THE FIELD INDICATED THAT APPROXIMATELY THREE WEEKS AFTER PRECISE STENT IMPLANTATION, THE PT HAD A MYOCARDIAL INFARCTION (MI) CAUSED BY THROMBOSIS OF A PREVIOUSLY IMPLANTED UNKNOWN CYPHER STENT IN THE CIRCUMFLEX CORONARY ARTERY. ATTEMPTS TO RE-ESTABLISH FLOW/RESUSCITATION WERE UNSUCCESSFUL AND THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| L