BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHYPER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 843894 · Received April 26, 2007

    Report

    Report Number
    9616099-2007-00759
    Event Type
    Injury
    Date Received
    April 26, 2007
    Date of Event
    March 16, 2007
    Report Date
    March 28, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: THIS 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 NUMBER IS 9616099-2007-000760. ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY A YEAR AND ONE-MONTH POST INDEX PROCEDURE, THE PT HAD A FOLLOW-UP CORONARY ANGIOGRAM DONE AND THERE WERE NOT ISSUES. A YEAR AND EIGHT DAYS LATER, THE PT COMPLAINED OF CHEST PAIN WHILE DRINKING AND CAME TO THE HOSP. AN ABNORMAL ELECTRO CARDIOGRAM WAS OBSERVED. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE CYPHER. TO TREAT THE THROMBUS, ASPIRATION AND PLAIN OLD BALLOON ANGIOPLASTY POBA WERE CONDUCTED WITH A 2.5 BALLOON. THE PATIENT HAD A TARGET LESION IN THE OBTUSE MARGINAL BRANCH. THE VESSEL WAS A TYPE C, CONCENTRIC, IN-STENT RESTENOSIS OF A BX STENT. THE LESION LENGTH WAS 30MM AND VESSEL DIAMETER WAS 3.0MM. IN 2005, THE PATIENT WENT IN FOR AN ELECTIVE CASE. A 2.5 X 23MM CYPHER STENT WAS IMPLANTED AT 18ATMS FOR 30SECONDS. A DISSECTION OCCURRED AT THE DISTAL PORTION OF THE CYPHER STENT AFTER IMPLANTATION. TO TREAT THE DISSECTION, PLAIN OLD BALLOON ANGIOPLASTY WAS CONDUCTED AT 10ATMS FOR 30 SECONDS. THE RESIDUAL PERCENTAGE OF STENOSIS WAS 0. TIMI FLOW GRADE WAS 1 PRE PROCEDURE AND 3 POST PROCEDURE. THE PHYSICIAN COMMENTED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE OF THE DISSECTION THAT OCCURRED WHERE THE CYPHER WAS IMPLANTED. TICLOPIDINE HYDROCHLORIDE WAS STOPPED AND THE PT HAD A RISK FACTOR OF ADIPOSITAS. IT WAS STOPPED IN 2006 SINCE THERE WAS NOT ISSUE CONFIRMED ON THE FOLLOW-UP CORONARY ANGIOGRAM.THE PT'S MEDICATIONS INCLUDE THE FOLLOWING: ASPIRIN AND TICLOPIDINE HYDROCHLORIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHYPER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA I1204127

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R