BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1213824 · Received October 28, 2008

    Report

    Report Number
    9616099-2008-02556
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    March 6, 2008
    Report Date
    October 7, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES, BUT IS SIMILAR TO US DISTRIBUTED STENT DELIVERY SYSTEMS. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTED CORONARY ARTERY STENTS. THE ACT OF CORONARY STENTING IN AN OSTIUM IS ASSOCIATED WITH A LOW SUCCESS RATE, HIGH RATE OF COMPLICATIONS AND A HIGH INCIDENCE OF TARGET VESSEL REVASCULARIZATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS VESSEL/LESION CHARACTERISTICS AND/OR THE NATURAL PROGRESSION OF CORONARY ARTERY DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, A PATIENT EXPERIENCED RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR FAMILY HISTORY OF CORONARY ARTERY DISEASE HYPERTENSION AND HYPERLIPIDEMIA. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS THE UNPROTECTED LEFT MAIN (LM) EXTENDING TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DE NOVO, 90% STENOSED AND AT THE OSTIUM. PRE-DILATION WAS CONDUCTED WITH A 3.0MM X 15MM BALLOON AT 10 ATMS FOLLOWED BY THE DEPLOYMENT OF A 3.5MM X 33M CYPHER SELECT PLUS STENT AT 12 ATMS. THE STENT WAS SUCCESSFULLY IMPLANTED AND DID NOT REQUIRE POST-DILATION. APPROXIMATELY EIGHT MONTHS LATER CLINICALLY DRIVEN ANGIOGRAPHY WAS PERFORMED. THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED A 95% RESTENOSIS IN THE PREVIOUSLY IMPLANTED CYPHER AND A NEW 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX ARTERY (CFX). THE RESTENOSIS WAS TREATED WITH POBA, THERE IS NO INFORMATION PERTAINING TO THE LESION IN THE CFX. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.

    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 13227620

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R 6FR GUIDING CATHETER| 3.0 X 15MM BALLOON