BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2324369 · Received November 4, 2011

    Report

    Report Number
    3003742446-2011-00459
    Event Type
    Death
    Date Received
    November 4, 2011
    Report Date
    October 12, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    VIRMANI ET AL IN STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE, JOURNAL OF CARDIOLOGY (2011) 58, 84-91. THE PATIENT WAS TREATED IN THE UNITED STATES, BUT THE INFORMATION WAS PROVIDED IN AN ARTICLE WRITTEN BY A (B)(4) PHYSICIAN ASSOCIATED WITH THE STUDY AND WAS REPORTED VIA OUR (B)(4) AFFILIATES. THE DATE OF STENT IMPLANTATION WAS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE OF ONE OF THE LITERATURE AUTHORS ON (B)(4) 2011. THE LOT AND CATALOG NUMBER OF THE STENT WAS UNKNOWN, BUT BASED ON HIGH DEFINITION X-RAY MEASUREMENT, THE SIZE OF THE STENT WAS 3.5 X 23MM. THE STENT WAS IMPLANTED IN (B)(6) 2003 IN THE PROXIMAL CIRCUMFLEX. FOLLOW-UP ANALYSIS SHOWED THE LESION HAD MILD CALCIFICATION WITH NO RESTENOSIS (ONLY MILD NEOINTIMAL THICKENING), BUT OCCLUSIVE PLATELET THROMBUS WAS IDENTIFIED IN THE DISTAL PORTION OF THE STENT. THE PATIENT HAD BEEN TAKING ASPIRIN, BUT NO CLOPIDOGREL OR OTHER ANTI-PLATELET DRUGS. THE CAUSE OF DEATH WAS VERY LATE STENT THROMBOSIS. HISTOLOGY SHOWED MALPOSITION OF THE STENT STRUTS. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY 24 MONTHS POST PROCEDURE THERE WAS LATE STENT MALPOSITION, THROMBOSIS AND THE PATIENT DIED. THIS COMPLAINT WAS REPORTED IN "STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE"; JOURNAL OF CARDIOLOGY 58, 84-91, 2011. THE PATIENT WAS PRESENTED IN THE FIGURE1, C. THE TARGET LESION WAS DE NOVO, BUT OTHER LESION INFORMATION WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE OF ONE OF THE LITERATURE AUTHORS. THE LOT AND CATALOG NUMBER OF THE STENT WAS UNKNOWN, BUT BASED ON HIGH DEFINITION X-RAY MEASUREMENT, THE SIZE OF THE STENT WAS 3.5 X 23MM. THE STENT WAS IMPLANTED IN (B)(6) 2003 IN THE PROXIMAL CIRCUMFLEX. TWENTY-FOUR MONTHS LATER, THE PATIENT DEVELOPED VERY LATE STENT THROMBOSIS OF THE CYPHER AND SUBSEQUENTLY DIED. FOLLOW-UP ANALYSIS SHOWED THE LESION HAD MILD CALCIFICATION WITH NO RESTENOSIS (ONLY MILD NEOINTIMAL THICKENING), BUT OCCLUSIVE PLATELET THROMBUS WAS IDENTIFIED IN THE DISTAL PORTION OF THE STENT. THE PATIENT HAD BEEN TAKING ASPIRIN, BUT NO CLOPIDOGREL OR OTHER ANTI-PLATELET DRUGS. THE CAUSE OF DEATH WAS VERY LATE STENT THROMBOSIS. HISTOLOGY SHOWED MALPOSITION OF THE STENT STRUTS AND MINIMAL COVERAGE OF THE STRUTS ABOVE NECROTIC CORE. THE STENT REMAINS UNAVAILABLE FOR ANALYSIS. THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR REVIEW COULD BE PERFORMED. STENT MALPOSITION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CYPHER STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS NOT KNOWN IF IVUS CONFIRMED COMPLETE APPOSITION OF THE STENTS OR IF THE STENTS WERE NOT COMPLETELY APPOSED TO THE INTIMAL SURFACE OF THE ARTERIAL WALL (INCOMPLETE STENT APPOSITION) DURING THE INDEX PROCEDURE. THERE IS A THEORETICAL CONCERN THAT INCOMPLETE STENT APPOSITION IN THE MIDDLE OF THE STENT CAN RESULT IN AREAS OF "CUL-DE-SAC" FORMATION WITH BLOOD-FLOW STAGNATION THAT CAN PREDISPOSE THE PATIENT TO STENT THROMBOSIS. SIROLIMUS HAS POTENT ANTI-INFLAMMATORY, IMMUNOSUPPRESSIVE, AND ANTIPROLIFERATIVE EFFECTS. THESE POTENT BIOLOGIC EFFECTS RAISE THEORETIC CONCERNS ABOUT POTENTIAL SIDE EFFECTS, SUCH AS INCOMPLETE HEALING, INCREASED THROMBOGENICITY, NECROSIS, APOPTOSIS, AND POSITIVE REMODELING. CONTINUED SURVEILLANCE AFTER DES IMPLANTATION IS REQUIRED TO DETERMINE THE LONG-TERM SAFETY. ANIMAL STUDIES HAVE SHOWN DELAYED ENDOTHELIALIZATION TO BE MORE COMMON IN OVERLAPPING STENT SEGMENTS THAN IN NON-OVERLAPPING STENT SEGMENTS FOR BOTH SIROLIMUS-ELUTING STENTS AND BARE METAL STENTS. VERY LATE THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. SIROLIMUS HAS POTENT ANTI-INFLAMMATORY, IMMUNOSUPPRESSIVE, AND ANTIPROLIFERATIVE EFFECTS. THESE POTENT BIOLOGIC EFFECTS RAISE THEORETIC CONCERNS ABOUT POTENTIAL SIDE EFFECTS, SUCH AS INCOMPLETE HEALING, INCREASED THROMBOGENICITY, NECROSIS, APOPTOSIS, AND POSITIVE REMODELING. CONTINUED SURVEILLANCE AFTER DES IMPLANTATION IS REQUIRED TO DETERMINE THE LONG-TERM SAFETY. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PATIENT, LESION AND VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REPORTED IN "STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE"; JOURNAL OF CARDIOLOGY 58, 84-91, 2011. THE PATIENT WAS PRESENTED IN THE FIGURE1, C. THE TARGET LESION WAS DE NOVO, BUT OTHER LESION INFORMATION WAS UNKNOWN. THE CYPHER WAS IMPLANTED ON AN UNKNOWN DATE DUE TO AN ACUTE MYOCARDIAL INFARCTION. A CYPHER (SIZE AND NUMBER OF UNIT WERE UNKNOWN) WAS IMPLANTED AT THE TARGET LESION. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING STENT IMPLANTATION. TWENTY-FOUR MONTHS LATER, THE PATIENT DEVELOPED VERY LATE STENT THROMBOSIS OF THE CYPHER. THE PATIENT LATER DIED DUE TO AN UNKNOWN CAUSE. AN AUTOPSY WAS CONDUCTED, BUT THROMBUS WAS NOT OBSERVED AT THE TIME. HISTOPATHOLOGICAL WORK-UP WAS CONDUCTED AND MINIMAL COVERAGE OF THE STRUTS ABOVE NECROTIC CORE WAS OBSERVED. THERE WILL BE NO FURTHER INFORMATION AVAILABLE FOR THIS EVENT.

    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 34 YR Death| O| R