BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 870981 · Received June 25, 2007

    Report

    Report Number
    9616099-2007-01167
    Event Type
    Injury
    Date Received
    June 25, 2007
    Date of Event
    May 20, 2007
    Report Date
    May 28, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S MEDICATIONS INCLUDE THE FOLLOWING: ASPIRIN, TICLOPIDINE HYDROCHLORIDE AND HEPARIN. PLEASE NOTE: THIS FOREIGN 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 MFR REPORT NUMBERS ARE 9616099-2007-001167 AND 9616099-2007-01168. ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING AN EIGHT MONTH F/U A CORONARY ANGIOGRAM WAS CONDUCTED AND THERE WERE NO ISSUED NOTED. APPROX A YEAR AND THREE MONTHS POST INDEX THE PT DEVELOPED AN ACUTE MYOCARDIAL INFARCTION. A CORONARY ANGIOGRAM WAS CONDUCTED AND A STENT FRACTURE WAS OBSERVED PROXIMAL AND DISTAL TO THE OVERLAPPING PORTION. THROMBUS WAS OBSERVED AT THE OVERLAPPING PORTION. A 3.5 X 16 MM LIBERTE BARE METAL STENT WAS IMPLANTED AT 15 ATMS FOR 30 SECONDS TO TREAT THE THROMBUS AND THE FRACTURE. THE PT HAD A TARGET LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. THE VESSEL WAS TYPE C, DE-NOVO, CALCIFIED AND TOTALLY OCCLUDED. THE LESION LENGTH WAS 40 MM AND VESSEL DIAMETER WAS 3.5 MM. IN 2006, THE PT WENT IN FOR AN ELECTIVE CASE. THE LESION WAS PRE-DILATED WITH A 3.0 X 20 MM BALLOON AT 14 ATMS FOR 20 SECONDS. A 3.0 X 33 MM CYPHER STENT WAS IMPLANTED AT 16 ATMS FOR 20 SECONDS. THEN A 3.5 X 23 MM CYPHER STENT WAS IMPLANTED AT 16 ATMS FOR 30 SECONDS PROXIMAL TO THE FIRST CYPHER STENT. THE TWO STENTS WERE OVERLAPPING EACH OTHER. POST-DILATION WAS CONDUCTED WITH A 3.0 X 20 MM BALLOON AT 16 ATMS FOR 20 SECONDS. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 0 AND TIMI FLOW PRE PROCEDURE WAS 0 AND 3 POST PROCEDURE. THE PHYSICIAN COMMENTED THAT THE THROMBOTIC EVENT WAS POSSIBLY DUE TO THE STENT FRACTURE AND THAT THE STENT FRACTURE WAS POSSIBLY DUE TO THE POSITION OF HINGE MOTION.

    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 I1105180

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R