BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1931058 · Received December 17, 2010

    Report

    Report Number
    9616099-2010-00976
    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

    PLEASE NOTE: THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCTS USED IN THE PROCEDURE ARE UNKNOWN. ALSO NOTE THAT THE EVENT DATE FOR THIS CASE IS UNKNOWN. THIS UNKNOWN (B)(4) CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00976, 9616099-2010-00977 AND 9616099-2010-00978. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00976, 9616099-2010-00977 AND 9616099-2010-00978.

    Additional Manufacturer Narrative · 1

    THIS UNKNOWN (B)(4) CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00976 AND 9616099-2010-00977. THIS COMPLAINT WAS RECEIVED VIA A LITERATURE FROM 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 PATIENT WAS ADMITTED FOR A PROCEDURE WITH STABLE CORONARY ARTERY DISEASE. THE PATIENT HAD A TOTALLY OCCLUDE LESION IN THE RIGHT CORONARY ARTERY, HOWEVER, THE DETAILS OF THE LESION WERE NO SPECIFIED. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. THE PATIENT HAD THREE CYPHER STENTS IMPLANTED. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. A FOLLOW-UP CORONARY ANGIOGRAM WAS CONDUCTED 6-9 MONTHS POST PROCEDURE AND A STENT FRACTURE/SEPARATION (POPMA IV) WAS OBSERVED, HOWEVER, NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE DIAMETER OF STENOSIS WAS 25%. 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. ADDITIONAL INFORMATION RECEIVED INDICATED THAT TWO OF THE THREE STENTS IMPLANTED WERE FRACTURED. 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/REOCLUSSION 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.

    Description of Event or Problem · 1

    A FOLLOW-UP CORONARY ANGIOGRAM WAS CONDUCTED 6-9 MONTHS POST PROCEDURE AND A STENT FRACTURE/SEPARATION (POPMA IV) WAS OBSERVED, HOWEVER, NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE DIAMETER OF STENOSIS WAS 25%. THIS COMPLAINT WAS RECEIVED VIA A LITERATURE FROM 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 PATIENT WAS ADMITTED FOR A PROCEDURE WITH STABLE CORONARY ARTERY DISEASE. THE PATIENT HAD A TOTALLY OCCLUDE LESION IN THE RIGHT CORONARY ARTERY, HOWEVER, THE DETAILS OF THE LESION WERE NO SPECIFIED. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. THE PATIENT HAD THREE CYPHER STENTS IMPLANTED. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION 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 47 YR