BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2324378 · Received November 4, 2011

    Report

    Report Number
    3003742446-2011-00460
    Event Type
    Injury
    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 INFORMATION WAS RECEIVED FROM THE SITE OF ONE OF THE LITERATURE AUTHORS ON 12/2/2011. THE LOT AND CATALOG NUMBER OF THE DEVICE WAS UNKNOWN, BUT BASED ON THE HIGH-DEFINITION X-RAY MEASUREMENT, THE SIZE OF THE STENT WAS 3.5 X 18MM. THE STENT WAS IMPLANTED IN (B)(6) 2005 IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. AT FOLLOW-UP, THERE WAS 75% LUMINAL NARROWING AT THE PROXIMAL LAD, BUT THE STENT IMPLANTED REGIONS SHOWED WIDELY OPEN LUMEN. THE CAUSE OF DEATH WAS SUICIDE. HISTOLOGY SHOWED NO MALAPPOSITION OF THE STENT. THE PATIENT HAD BEEN PRESCRIBED DUAL ANTI-PLATELET THERAPY (ASPIRIN AND CLOPIDOGREL), BUT IS AS UNKNOWN IF THE PATIENT HAD BEEN COMPLIANT WITH THERAPY. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY 13 MONTHS POST PROCEDURE, THERE WAS LATE STENT MALAPPOSITION AND THE PATIENT DIED. THIS COMPLAINT WAS REPORTED IN "STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE"; JOURNAL OF CARDIOLOGY 58, 84-91, 2011. THIS WAS A (B)(6) MALE PATIENT WITH MEDICAL HISTORY INCLUDING MI. ON AN UNKNOWN DATE, A CYPHER (SIZE AND NUMBER OF UNITS WERE UNKNOWN) WAS IMPLANTED AT THE TARGET LESION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE OF ONE OF THE LITERATURE AUTHORS ON 12/2/2011. THE LOT AND CATALOG NUMBER OF THE DEVICE WAS UNKNOWN, BUT BASED ON THE HIGH-DEFINITION X-RAY MEASUREMENT, THE SIZE OF THE STENT WAS 3.5 X 18MM. THE STENT WAS IMPLANTED IN (B)(6) 2005 IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. APPROXIMATELY 13 MONTHS POST PROCEDURE THE PATIENT DIED. AT FOLLOW-UP, THERE WAS 75% LUMINAL NARROWING AT THE PROXIMAL LAD, BUT THE STENT IMPLANTED REGIONS SHOWED WIDELY OPEN LUMEN. HISTOPATHOLOGICAL WORK-UP WAS CONDUCTED AND MINIMAL COVERAGE OF STRUTS ABOVE NECROTIC CORE (NC) WAS OBSERVED AT THE CYPHER. THE CAUSE OF DEATH WAS SUICIDE. THE PATIENT HAD BEEN PRESCRIBED DUAL ANTI-PLATELET THERAPY (ASPIRIN AND CLOPIDOGREL), BUT IT WAS UNKNOWN IF THE PATIENT HAD BEEN COMPLIANT WITH THERAPY. THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR REVIEW COULD BE PERFORMED. STENT MALAPPOSITION 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. 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.

    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)(6) PHYSICIAN ASSOCIATED WITH THE STUDY AND WAS REPORTED VIA OUR (B)(6) AFFILIATES. THE DATE OF STENT IMPLANTATION WAS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 FIGURE 1, B OF THE ARTICLE. THE TARGET LESION AND LESION INFORMATION WAS NOT PROVIDED. ON AN UNKNOWN DATE, A CYPHER (SIZE AND NUMBER OF UNITS WERE UNKNOWN) WAS IMPLANTED AT THE TARGET LESION. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE STENT IMPLANTATION. THIRTEEN MONTHS AFTER THE IMPLANTATION, THE PATIENT DIED DUE TO A NON-CARDIAC CAUSE. AN AUTOPSY WAS PERFORMED. HISTOPATHOLOGICAL WORK-UP WAS CONDUCTED AND MINIMAL COVERAGE OF STRUTS ABOVE NECROTIC CORE (NC) WAS OBSERVED AT THE CYPHER.

    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 49 YR Other