BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1222514 · Received November 6, 2008

    Report

    Report Number
    3003742446-2008-00254
    Event Type
    Injury
    Date Received
    November 6, 2008
    Report Date
    October 9, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS PROGRESSIVE EXERTIONAL ANGINA. THE PATIENT HAD STRESS ECHOCARDIOGRAPHY DONE THAT RESULTED IN ANGINA, ANTERIOR ST-SEGMENT DEPRESSION, AND ANTERIOR WALL HYPOKINESIS. CORONARY ANGIOGRAPHY WAS DONE AND THE PATIENT WAS NOTED TO HAVE SINGLE-VESSEL DISEASE. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS A 70% TUBULAR STENOSIS WITHIN A MID LAD MYOCARDIAL BRIDGE. THE FIRST DIAGONAL WAS FOUND TO HAVE A PROXIMAL 80% STENOSIS. A 2.75X32 MM TAXUS STENT AND 2.5 X 28 MM CYPHER STENT WERE IMPLANTED IN OVERLAPPING FASHION WITH AN EXCELLENT RESULT OBTAINED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH ENTITLED: "STENT FRACTURE FOLLOWING STENTING OF A MYOCARDIAL BRIDGE: REPORT OF TWO CASES". THE ARTICLE WAS PUBLISHED IN CATHETERIZATION AND CARDIOVASCULAR INTERVENTION 71:191-196 (2008). CASE#1: A MALE WHO WAS TREATED WITH A 2.75X32 MM TAXUS AND A 2.5X28MM CYPHER IN AN OVERLAPPING MANNER. FIVE WEEKS AFTER THE INDEX PROCEDURE, AFTER PERSISTENT ANGINAL SYMPTOMS, ANGIOGRAPHY WAS DONE AND REVEALED IN-STENT-RESTENOSIS (ISR) AND STENT FRACTURE OF THE PREVIOUSLY IMPLANTED TAXUS STENT. THERE WAS ALSO A HIGH-GRADE STENOSIS AT THE PROXIMAL STENT MARGIN. THE OVERLAPPED STENTED SEGMENT WAS REPORTED TO BE UNDER-EXPANDED. THE PATIENT SUBSEQUENTLY UNDERWENT CORONARY ARTERY BYPASS TO THE LAD AND DIAGONAL WITHOUT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening| H| R TAXUS 2.75X32MM STENT| TAXUS 2.75X32MM STENT