BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1953864 · Received January 10, 2011

    Report

    Report Number
    3003742446-2011-00028
    Event Type
    Death
    Date Received
    January 10, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B)(4), A (B)(6) MALE PATIENT EXPIRED DUE TO ACUTE MYOCARDIAL INFARCTION AND CARDIAC ARREST APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDED HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, PREVIOUS PCI ((B)(6) 2006), PREVIOUS CABG ((B)(6) 2006), HISTORY OF MYOCARDIAL INFARCTION ((B)(6) 2002), HISTORY OF COPD, HISTORY OF DVT, HISTORY OF CHRONIC BACK PAIN AND PAST SMOKER. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS OF THE SAPHENOUS VEIN GRAFT TO SECOND OBTUSE MARGINAL. THIS PRODUCT IS INDICATED IN DE NOVO LESIONS IN NATIVE CORONARIES. THE LESION WAS DESCRIBED AS DE NOVO, AND 23MM IN LENGTH. PRE-PROCEDURE TIMI FLOW WAS 2. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE LESION WAS PRE-DILATED WITH A 2.0 X 12MM BALLOON AT 14ATM AND A 3.0 X 23MM CYPHER RX WAS IMPLANTED AT 14ATM AT THE TARGET LESION. THE STENT WAS NOT POST-DILATED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT COLLAPSED WHILE DRIVING WITH HIS WIFE. CARDIOPULMONARY RESUSCITATION WAS INITIATED DUE TO ASYSTOLE AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. ACCORDING TO THE CASE REPORT FORM, THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. NO TESTING WAS PERFORMED TO DETERMINE IF THE STENT WAS PATENT AND NO AUTOPSY WAS PERFORMED. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DEATH IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THIS PATIENT'S DEATH. HOWEVER, THERE ARE EXTENSIVE RISK FACTORS PRESENT IN THE PATIENT'S MEDICAL HISTORY AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    UPDATED COMPLAINT CONCLUSION BASED ON ADDITIONAL INFORMATION FROM ADJUDICATION: AS REPORTED VIA THE (B)(4) STUDY, A (B)(6) MALE PATIENT EXPIRED DUE TO ACUTE MYOCARDIAL INFARCTION AND CARDIAC ARREST WITH POSSIBLE STENT THROMBOSIS APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDED HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, PREVIOUS PCI ((B)(6) 2006), PREVIOUS CABG ((B)(6) 2006), HISTORY OF MYOCARDIAL INFARCTION ((B)(6) 2002), HISTORY OF COPD, HISTORY OF DVT, HISTORY OF CHRONIC BACK PAIN AND PAST SMOKER. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS OF THE SAPHENOUS VEIN GRAFT TO SECOND OBTUSE MARGINAL. THIS PRODUCT IS INDICATED IN DE NOVO LESIONS IN NATIVE CORONARIES. THE LESION WAS DESCRIBED AS DE NOVO, AND 23MM IN LENGTH. PRE-PROCEDURE TIMI FLOW WAS 2. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE LESION WAS PRE-DILATED WITH A 2.0 X 12MM BALLOON AT 14ATM AND A 3.0 X 23MM CYPHER RX WAS IMPLANTED AT 14ATM AT THE TARGET LESION. THE STENT WAS NOT POST-DILATED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. OF NOTE THE DATABASE ONLY LISTS ASPIRIN 81 KG ONCE DAILY AS THE ONLY ANTI-PLATELET AGENT AT DISCHARGE. APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT COLLAPSED WHILE DRIVING WITH HIS WIFE. CARDIOPULMONARY RESUSCITATION WAS INITIATED DUE TO ASYSTOLE AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. ACCORDING TO THE CASE REPORT FORM, THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. NO TESTING WAS PERFORMED TO DETERMINE IF THE STENT WAS PATENT AND NO AUTOPSY WAS PERFORMED. THE MINUTES OF THE CEC ADJUDICATED THAT THERE WAS POSSIBLE STENT THROMBOSIS PER ARC, MEANING ANY UNEXPLAINED DEATH AFTER 30 DAYS OF IMPLANT, SINCE THERE IS NO ANGIOGRAPHIC EVIDENCE TO DISPUTE THE POSSIBILITY, THE CODE OF STENT THROMBOSIS WILL BE ADDED AND PROCESSED ACCORDINGLY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. MYOCARDIAL INFARCTION, POSSIBLE STENT THROMBOSIS AND DEATH ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THIS PATIENT¿S DEATH. HOWEVER, THERE ARE EXTENSIVE RISK FACTORS PRESENT IN THE PATIENT¿S MEDICAL HISTORY AND/OR PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED O THE REPORTED EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS AT THE TIME OF DEATH: FOSINOPRIL 5MG DAILY SINCE 2006. TOPROL 25MG DAILY SINCE 2002. ASPIRIN 81MD DAILY SINCE 1989. FLEXERIL 10MG AS NEEDED SINCE 2005. ZOCOR 40MG SINCE (B)(6) 2010. CLOPIDOGREL 75MG SINCE (B)(6) 2010. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION AND EXPIRED DUE TO CARDIAC ARREST APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT COLLAPSED WHILE DRIVING WITH HIS WIFE. CARDIOPULMONARY RESUSITATION WAS INTIATED DUE TO ASYSTOLE AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. ACCORDING TO THE CASE REPORT FORM, THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. NO TESTING WAS PERFORMED TO DETERMINE IF THE STENT WAS PATENT AND NO AUTOPSY WAS PERFORMED. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS OF THE SAPHENOUS VEIN GRAFT TO SECOND OBTUSE MARGINAL. THE LESION WAS DESCRIBED AS DE NOVO, AND 23MM IN LENGTH. PRE-PROCEDURE TIMI FLOW WAS 2. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE LESION WAS PRE-DILATED WITH A 2.0 X 12MM BALLOON AT 14ATM AND A 3.0 X 23MM CYPHER RX WAS IMPLANTED AT 14ATM AT THE TARGET LESION. THE STENT WAS NOT POST-DILATED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Description of Event or Problem · 1

    CEC ADJUDICATION MINUTES WERE RECEIVED ON (B)(6), 2011. BECAUSE THE COMMITTEE HAD INDICATED THAT THERE IS A POSSIBLE STENT THROMBOSIS PER ARC (MEANING ANY UNEXPLAINED DEATH AFTER 30 DAYS OF IMPLANT AND WITH NO ANGIOGRAPHIC EVIDENCE TO DISPUTE THE POSSIBILITY), THE CODE OF STENT THROMBOSIS WILL BE ADDED.

    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 15054757

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death