BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083466 · Received July 28, 2008

    Report

    Report Number
    3003742446-2008-00139
    Event Type
    Death
    Date Received
    July 28, 2008
    Date of Event
    June 15, 2007
    Report Date
    June 30, 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

    PLEASE NOTE THAT THIS REPORT IS FOR TWO PRODUCTS WITH UNKNOWN CATALOG AND LOT NUMBERS. THE PRODUCTS ARE NOT AVAILABLE FOR EVALUATION AND TESTING. THIS MALE PATIENT OF UNKNOWN MEDICAL HISTORY EXPERIENCED A THROMBOTIC EVENT APPROXIMATELY 14 MONTHS POST IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT STOPPED THE ANTIPLATELET THERAPY IN PREPARATION FOR SURGERY OF A COLON MASS. THREE DAYS AFTER SURGERY, THE PATIENT HAD A THROMBOTIC EVENT AND THREE DAYS LATER, THE PATIENT HAD A CARDIOPULMONARY ARREST AND SUBSEQUENTLY DIED. THE INDICATION OF THE INDEX PROCEDURE WAS AN ST ELEVATION MYOCARDIAL INFARCTION (STEMI). PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. DESCRIPTION OF THE VESSEL SUCH AS PERCENTAGE OF STENOSIS, TORTUOSITY, PRESENCE OF CALCIFICATION, ETC, WAS NOT REPORTED. VESSEL CLASSIFICATION WAS NOT REPORTED. THERE IS NO INFORMATION REGARDING PROCEDURAL DETAILS SUCH AS: DEBULKING OR PRE-DILATION OF LESION BEFORE STENT DEPLOYMENT, PRE AND POST PROCEDURE CARDIAC ENZYME VALUES, PRE AND INTRA PROCEDURE MEDICATIONS USED. A 3.5X13MM AND A 3.5X8MM CYPHER STENTS WERE IMPLANTED IN AN UNKNOWN SEGMENT OF THE CIRCUMFLEX ARTERY. THE PRESSURE OF DEPLOYMENT WAS UNKNOWN. THE LOT NUMBERS AND EXPIRATION DATES WERE UNKNOWN. IT WAS UNKNOWN IF THE STENTS WERE OVERLAPPING OR ABUTTING. POST-DILATION OF THE STENTS WAS NOT REPORTED. THE RESIDUAL DIAMETER STENOSIS WAS NOT REPORTED. TIMI FLOW WAS NOT REPORTED. THE REPORT INDICATES THAT ASPIRIN AND PLAVIX WERE PRESCRIBED AT DISCHARGE. APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE, THE PATIENT STOPPED TREATMENT OF ASPIRIN AND PLAVIX SEVEN DAYS PRIOR TO AN ELECTIVE SURGERY FOR COLON CANCER. THREE DAYS POST COLON SURGERY, THE PATIENT EXPERIENCED CHEST PAIN AND HYPOTENSION. CORONARY ANGIOGRAPHY REVEALED A THROMBUS IN THE SECOND CYPHER STENT IMPLANTED IN THE CIRCUMFLEX. IT WAS NOT INDICATED WHICH STENT WAS IMPLANTED FIRST TO BE ABLE TO IDENTIFY WHICH STENT HAD THE THROMBUS. THE PATIENT WAS TREATED WITH ANGIOPLASTY. DETAILS OF THIS PROCEDURE WERE NOT PROVIDED. THREE DAYS POST THROMBOTIC EVENT, THE PATIENT DIED DUE TO CARDIOPULMONARY ARREST. AN AUTOPSY REPORT WAS NOT PROVIDED. THE PRODUCTS REMAINED IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS OF THE PRODUCTS WERE NOT REPORTED. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. THE IFU WARNS THAT THE USE OF THIS DEVICE CARRIES THE ASSOCIATED RISKS OF SUB-ACUTE THROMBOSIS, VASCULAR COMPLICATION AND/OR BLEEDING EVENTS. WITH SUCH LIMITED PATIENT AND PROCEDURAL INFORMATION AVAILABLE FOR REVIEW, THE LACK OF AVAILABILITY OF PRODUCT LOT NUMBER TO PERFORM A DHR REVIEW AND THE UNAVAILABILITY OF THE PRODUCT FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THESE EVENTS. HOWEVER, THERE ARE PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S THROMBOTIC EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THESE PRODUCTS.

    Description of Event or Problem · 1

    THE REPORT RECEIVED THROUGH THE LEGAL DEPARTMENT INDICATED THAT APPROXIMATELY FOURTEEN MONTHS AFTER IMPLANTATION OF TWO CYPHER STENTS, THE PATIENT STOPPED TAKING HIS ANTIPLATELET THERAPY SEVEN DAYS PRIOR TO AND IN PREPARATION FOR ELECTIVE SURGERY FOR COLON CANCER. THREE DAYS AFTER THE SURGERY, THE PATIENT EXPERIENCED CHEST PAIN AND HYPOTENSION. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS REPORTED IN THE SECOND STENT IMPLANTED IN THE CIRCUMFLEX CORONARY ARTERY. THE THROMBOTIC EVENT WAS TREATED BY BALLOON ANGIOPLASTY. THREE DAYS AFTER THE THROMBOTIC EVENT, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST AND EXPIRED. IT IS NOT KNOW IF AN AUTOPSY WAS PERFORMED.

    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 56 YR Death| H| L| R