BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1930595 · Received December 16, 2010

    Report

    Report Number
    9616099-2010-00969
    Event Type
    Malfunction
    Date Received
    December 16, 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

    REPORT OF A CYPHER BX STENT FRACTURE 6-9 MONTHS POST IMPLANTATION OF 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. IT WAS INDICATED THAT THE CLINICAL OUTCOME WAS EVENT FREE. THE PATIENT WAS A (B)(4). THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE LEFT CIRCUMFLEX (LCX) BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR A CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT PATIENTS WITH INAPPROPRIATE VESSEL SIZE WERE EXCLUDED. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. AT INDEX PROCEDURE A CYPHER BX (2.5/18MM, LOT UNKNOWN) WAS IMPLANTED. HOWEVER, THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6 TO 9 MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RATE OF STENOSIS WAS 39% AND POPMA ET AL CLASSIFICATION WAS III (COMPLETE SEPARATION WITHOUT DISPLACEMENT). DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. 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. LONGER STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. IN ADDITION TO PROGRESSION OF EXISTING DISEASE, 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 IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON 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. THIS CASE IS 13TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE LEFT CIRCUMFLEX (LCX) BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR A CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WAS UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, A CYPHER BX (2.5/18MM, LOT UNKNOWN) WAS IMPLANTED. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6 TO 9 MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RATE OF STENOSIS WAS 39% AND POPMA ET AL CLASSIFICATION WAS III. AFTER THIS FINDING, THE PATIENT'S CLINICAL OUTCOME WAS EVENT FREE. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN

    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 65 YR Hospitalization| L| R