BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001509 · Received February 20, 2008

    Report

    Report Number
    9616099-2008-00395
    Event Type
    Injury
    Date Received
    February 20, 2008
    Report Date
    January 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT PLUS 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 ADVANCE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2008-00395 AND 9616099-2008-00396. THIS REPORT OF STENT FRACTURE OF 2 CYPHER STENTS WAS IDENTIFIED UPON LITERATURE REVIEW. THE ARTICLE WAS ENTITLED "FREQUENCY OF STENT FRACTURE AS A CAUSE OF CORONARY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION". ATTEMPTS TO OBTAIN CLINICAL AND PROCEDURAL DETAILS WERE UNSUCCESSFUL. THE STENT FRACTURE, AS WELL AS RESTENOSIS, WAS IDENTIFIED ON 9-MONTH FOLLOW-UP ANGIOGRAPHY. TREATMENT WAS NOT REPORTED. THE STENTS WERE NOT RETURNED FOR EVALUATION; THEY REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. 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. IN THE ABSENCE OF CLINICAL AND PROCEDURAL DETAILS, IT IS NOT POSSIBLE TO DETERMINE WITH ANY CERTAINTY WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS FOUND VIA LITERATURE REVIEW. THE ARTICLE WAS ENTITLED "FREQUENCY OF STENT FRACTURE AS A CAUSE OF CORONARY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION". THE PATIENT HAD A LESION IN THE RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED USING OPTIMAL BALLOON DILATION AND THEN A 3.5 X 23MM CYPHER STENT AND A 3.0 X 23MM CYPHER STENT WERE IMPLANTED IN THE LESION. DURING NINE-MONTH FOLLOW-UP, IT WAS NOTED THAT THE PATIENT HAD A STENT FRACTURE AND RESTENOSIS IN THE STENTS THAT HAD BEEN PREVIOUS IMPLANTED. THE PATIENT'S MEDICATIONS INCLUDED ASPIRIN.

    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 50 YR Life Threatening