BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1930604 · Received December 16, 2010

    Report

    Report Number
    9616099-2010-00963
    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

    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)(4) HOSPITAL AND (B)(4) MEDICAL UNIVERSITY. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LAD BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN ISR BUT IT WAS A 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, TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 43MM AND THE STENT DIAMETER WAS 2.5MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6~9MONTHS 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 %DS WAS 30% AT THE 1ST CAG AND 28% AT THE 2ND CAG. POPMA ET AL CLASSIFICATION WAS II. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MULTIPLE ATTEMPTS TO DETERMINE WHICH OF THE TWO CYPHER STENTS WAS FRACTURED WERE UNSUCCESSFUL. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE AND THEREFORE BOTH CYPHER STENTS WILL BE REPORTED WITH FRACTURE AND REOCCLUSION. REOCCLUSION/RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. STENT DAMAGE/DEFORMATION AND RESTENOSIS/REOCCLUSION ARE KNOWN ADVERSE EVENTS INDICATED IN THE IFU. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. HOWEVER, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE EVENT DATE IS UNKNOWN. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2010-00964. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF 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) UNIVERSITY. THIS CASE IS 17TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) OLD MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LAD BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN ISR BUT IT WAS A 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, TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 43MM AND THE STENT DIAMETER WAS 2.5MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6-9 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 %DS WAS 30% AT THE 1ST CAG AND 28% AT THE 2ND CAG. POPMA ET AL CLASSIFICATION WAS II.

    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 74 YR Hospitalization| R