BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1101842 · Received August 6, 2008

    Report

    Report Number
    9616099-2008-01928
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    May 21, 2008
    Report Date
    July 9, 2008
    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

    A REPORT RECEIVED FROM AN AFFILIATE INDICATED THAT A PATIENT EXPERIENCED A THROMBOTIC EVENT AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA PECTORIS, PREVIOUS MYOCARDIAL INFARCTION AND DIABETES. THE PATIENT'S HISTORY PUTS THEM AT INCREASED RISK OF A MACE. THE INDICATION FOR THE PROCEDURE AND THE VESSEL CHARACTERISTICS ARE UNKNOWN. THE TARGET LESION, THE PROXIMAL TO THE DISTAL CIRCUMFLEX ARTERY (CFX). THE LESION WAS PRE-DILATED FOLLOWED BY THE DEPLOYMENT OF A 3.0MM X 23MM CYPHER STENT AT 20ATMS. A 3.5MM X 23MM CYPHER STENT WAS THEN IMPLANTED PROXIMAL AND OVERLAPPING TO THE FIRST ALSO AT 20ATMS. THE STENTS WERE POST-DILATED FOR OPTIMAL EXPANSION AND THE RESIDUAL PERCENT OF STENOSIS WAS REPORTED AS 0%. APPROXIMATELY THREE AND A HALF YEARS LATER, ANGIOGRAPHY WAS PERFORMED FOR COMPLAINTS OF EXERTIONAL CHEST TIGHTNESS. THE ANGIOGRAPHY REVEALED THROMBUS PROXIMAL TO IN THE IMPLANTED CYPHER STENTS. THE EVENT WAS TREATED WITH POBA AND ADDITIONAL IMPLANT OF TWO TAXUS STENTS IN THE CYPHER FROM THE PROXIMAL END. THE START DATE AND END DATE FOR TICLID AT 200MG PER DAY IS NOT KNOWN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WAS REVIEWED FOR THROMBOSIS. VERY LATE THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE LIMITED AMOUNT OF AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT, BUT THERE MAY HAVE BEEN VESSEL/LESION CHARACTERISTICS, PATIENT FACTORS AND/OR POSSIBLE PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2008-01927 AND 9616099-2008-01928. THESE CYPHER SIROLIMUS-ELUTING CORONARY STENTS ARE DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, THEY ARE SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENTS.

    Description of Event or Problem · 1

    THREE YEARS AND FIVE MONTHS POST STENT IMPLANTATION, THE PATIENT HAD EXERTIONAL TIGHTNESS OF THE CHEST FROM ONE MONTH AGO AND WENT TO THE HOSPITAL. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE CYPHER STENTS PREVIOUSLY IMPLANTED. TO TREAT THE THROMBUS BALLOON ANGIOPLASTY WAS CONDUCTED AND TWO TAXUS STENTS (3.0 X 32MM AND 3.5 X 32MM) WERE IMPLANTED IN THE CYPHERS FROM THE PROXIMAL END. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE TARGET LESION WAS A DE NOVO, TYPE C LEFT CIRCUMFLEX. THE LESION LENGTH WAS 30.3MM AND THE VESSEL DIAMETER WAS 2.67MM. IN LATE 2004, THE PATIENT HAD TWO STENTS IMPLANTED. THE LESION WAS PRE-DILATED AND A 3.0 X 23 MM CYPHER STENT WAS ELECTIVELY IMPLANTED DISTALLY AT 20AM FOR 60 SECONDS. THEN A 3.5 X 23MM CYPHER WAS IMPLANTED AT 20ATM FOR 60 SECONDS PROXIMAL TO THE FIRST STENT. THE STENTS WERE OVERLAPPING. THE STENTS WERE POST-DILATED. IVUS WAS CONDUCTED AND THE RESIDUAL STENOSIS WAS 0%.

    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 I1104003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R