BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2003795 · Received March 1, 2011

    Report

    Report Number
    3003742446-2011-00116
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    June 17, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED A MYOCARDIAL INFARCTION AND DIED APPROXIMATELY EIGHT MONTHS POST IMPLANTATION OF A CYPHER STENT. THE PATIENT HAD A HISTORY OF ANGINA, HYPERLIPIDEMIA, HYPERTENSION, LVEF 30-39%, MYOCARDIAL INFARCTION, GLAUCOMA, DEPRESSION, HAND TREMORS, AND ANXIETY DISORDER. THE TARGET LESION WAS THE 1ST OBTUSE MARGINAL. THE TARGET LESION WAS 2.25MM IN DIAMETER AND 15MM LONG. THE LESION WAS A TYPE A CLASSIFICATION AND DE NOVO. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 6 X 20MM BALLOON AT 12ATM. A 2.25X18MM CYPHER WAS DEPLOYED AT THE TARGET LESION AT 11ATM AND POST-DILATED WITH A 2.25 X 12MM BALLOON AT 16ATM. POST-PROCEDURE STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY 12 DAYS POST-PROCEDURE, THE PATIENT BEGAN EXPERIENCING ATYPICAL MODERATE CHEST PAIN AND GASTRIC DISCOMFORT. THE PATIENT WAS MEDICALLY MANAGED AND A DIAGNOSTIC ANGIOGRAM WAS PERFORMED. THE EVENTS WERE NOTED AS UNRELATED TO THE PROCEDURE AND CYPHER STENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY 8 ½ MONTHS POST-PROCEDURE, THE PATIENT HAD A FATAL MYOCARDIAL INFARCTION. AN ANGIOGRAM WAS NOT PERFORMED. AN AUTOPSY WAS NOT PERFORMED. THE STUDY SITE REPORTED THE DEATH WAS EVALUATED AS A CARDIAC DEATH. 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. MYOCARDIAL INFARCTION RESULTING IN DEATH IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE INFORMATION AVAILABLE SUGGESTS THAT THERE ARE PATIENT FACTORS (ADVANCED AGE AND LVEF 30-39%) THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED A MYOCARDIAL INFARCTION, STENT THROMBOSIS AND DIED APPROXIMATELY EIGHT MONTHS POST IMPLANTATION OF A CYPHER STENT. THE PATIENT HAD A HISTORY OF ANGINA, HYPERLIPIDEMIA, HYPERTENSION, LVEF 30-39%, MYOCARDIAL INFARCTION, GLAUCOMA, DEPRESSION, HAND TREMORS, AND ANXIETY DISORDER. THE TARGET LESION WAS THE 1ST OBTUSE MARGINAL. THE TARGET LESION WAS 2.25MM IN DIAMETER AND 15MM LONG. THE LESION WAS A TYPE A CLASSIFICATION AND DE NOVO. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 6 X 20MM BALLOON AT 12ATM. A 2.25X18MM CYPHER WAS DEPLOYED AT THE TARGET LESION AT 11ATM AND POST-DILATED WITH A 2.25 X 12MM BALLOON AT 16ATM. POST-PROCEDURE STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY 12 DAYS POST-PROCEDURE, THE PATIENT BEGAN EXPERIENCING ATYPICAL MODERATE CHEST PAIN AND GASTRIC DISCOMFORT. THE PATIENT WAS MEDICALLY MANAGED AND A DIAGNOSTIC ANGIOGRAM WAS PERFORMED. THE EVENTS WERE NOTED AS UNRELATED TO THE PROCEDURE AND CYPHER STENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY 8 ½ MONTHS POST-PROCEDURE; THE PATIENT HAD A FATAL MYOCARDIAL INFARCTION WITH STENT THROMBOSIS. AN ANGIOGRAM WAS NOT PERFORMED. AN AUTOPSY WAS NOT PERFORMED. THE STUDY SITE REPORTED THE DEATH WAS EVALUATED AS A CARDIAC, RELATED TO DEVICE, UNKNOWN VESSEL AND STENT THROMBOSIS (ARC DEFINITION). 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. MYOCARDIAL INFARCTION AND STENT THROMBOSIS RESULTING IN DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE INFORMATION AVAILABLE SUGGESTS THAT THERE ARE PATIENT FACTORS (ADVANCED AGE AND LVEF 30-39%) THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. 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.

    Description of Event or Problem · 1

    THE REPORT WAS FROM THE (B)(4) STUDY. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF ANGINA, HYPERLIPIDEMIA, HYPERTENSION, LVEF 30-39%, MYOCARDIAL INFARCTION, GLAUCOMA, DEPRESSION, HAND TREMORS, AND ANXIETY DISORDER. THE TARGET LESION WAS THE 1ST OB MARGINAL. THE TARGET LESION WAS 2.25MM IN DIAMETER AND 15MM LONG. THE LESION WAS A TYPE A CLASSIFICATION AND DE NOVO. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 6 X 20MM BALLOON AT 12ATM. A (B)(4) WAS DEPLOYED AT THE TARGET LESION AT 11ATM AND POST-DILATED WITH A 2.25 X 12MM BALLOON AT 16ATM. POST-PROCEDURE STENOSIS WAS 0%. PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY 8 ½ MONTHS POST-PROCEDURE, THE PATIENT HAD A FATAL MYOCARDIAL INFARCTION. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ADDENDUM RECEIVED (B)(6) 2011: PER THE ADJUDICATION, STENT THROMBOSIS WAS INVOLVED IN THE DEATH.

    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 15129413

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death