BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1932171 · Received December 17, 2010

    Report

    Report Number
    9616099-2010-00994
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED IN AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9. ''SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION'' THAT REPORT OF A 3.0X33MM CYPHER BX STENT FRACTURE 6-9 MONTHS POST IMPLANTATION WITH NO BINARY RESTENOSIS (DEFINED AS >50%) AT THE FRACTURE SITE WAS NOTED IN AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9. ''SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION'', YASUSHI INO, ET. AL, WAKAYAMA, JAPAN. THE LOCATION OF THE STENT FRACTURE WAS IS UNKNOWN. THE %DIAMETER STENOSIS (DS) WAS 30% AND POPMA ET AL CLASSIFICATION WAS III (COMPLETE SEPARATION WITHOUT DISPLACEMENT) WAS REPORTED. THE SECOND FOLLOW UP ANGIOGRAM WAS PERFORMED 22 MONTHS AFTER THE IMPLANT. THE % DS WAS 28%. AFTER THAT, THE PATIENT'S CLINICAL OUTCOME WAS EVENT FREE. THE INDICATION FOR THE INDEX PROCEDURE IN THE (B)(6) MALE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). IT WAS NEITHER AN INSTENT RESTENOSIS (ISR) NOR CHRONIC TOTAL OCCLUSION (CTO) LESION. OTHER DETAILS INCLUDING VESSEL DIAMETER, LESION LENGTH, AHA/ACC CLASSIFICATION OR PRE-PROCEDURE STENOSIS ARE NOT KNOWN. HOWEVER, IT WAS REPORTED THAT PATIENTS WITH INAPPROPRIATE VESSEL SIZE WERE EXCLUDED. THERE IS NO FURTHER INFORMATION REGARDING THE IMPLANTATION OF THE 3.0X33 CYPHER BX. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. THE STUDY CONCLUDED THAT LATE RESTENOSIS WAS NOT OBSERVED IN STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS DURING THE MIDTERM FOLLOW-UP AFTER STENT IMPLANTATION. IT FURTHER REPORTED THAT CLOSE FOLLOW-UP SHOULD BE PERFORMED IN PATIENTS WITH STENT FRACTURE SINCE THE RISK OF VERY LATE STENT THROMBOSIS IN STENT FRACTURE SITES AFTER MIDTERM FOLLOW-UP IS STILL UNKNOWN. THE STENT REMAINS IMPLANTED AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. TYPICALLY THE RIGHT CORONARY ARTERY (RCA) HAS MORE MOTION THAN OTHER CORONARY ARTERIES. LONGER STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. BASED ON THE LIMITED PROCEDURAL INFORMATION, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENT; HOWEVER, PROCEDURAL AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. PLEASE NOTE THAT THE CATALOG NUMBER IS NOT KNOWN. THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THE EVENT DATE IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9, "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THE LITERATURE IS FROM (B)(6) HOSPITAL AND (B)(6) MEDICAL UNIVERSITY. THE PATIENT WAS ADMITTED TO THE INDEX PROCEDURE WITH STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR A CTO LESION. A 3.0 X 33MM CYPHER BX STENT WAS IMPLANTED AT THE TARGET LESION. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6-9 MONTHS AFTER THE IMPLANT AND REVEALED STENT FRACTURE, BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE DIAMETER STENOSIS (DS) OF THE TARGET LESION WAS 30%. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE FRACTURED STENT COMPLETELY SEPARATED. THE SECOND FOLLOW UP ANGIOGRAM WAS PERFORMED 22 MONTHS AFTER THE IMPLANT AND REVEALED A DS OF 28%.THE POPMA ET. AL. CLASSIFICATION WAS III. THE PATIENT'S CLINICAL OUTCOME WAS EVENT FREE. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. THE SECOND FOLLOW UP ANGIOGRAPHY WAS PERFORMED > 15 MONTHS AFTER SES IMPLANTATION AND REVEALED 28% DIAMETER STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R