BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1062867 · Received June 18, 2008

    Report

    Report Number
    9616099-2008-01550
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    December 17, 2007
    Report Date
    May 22, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBER IS 9616099-2008-01551. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AT THE 6 MONTH FOLLOW-UP (2007), THE PT WAS EXPERIENCING ANGINA PECTORIS. SEVEN MONTHS POST-PROCEDURE (THE FOLLOWING MONTH), THE PT REPORTED HE HAD A CLINICALLY DRIVEN STAGED PROCEDURE AT ANOTHER HOSPITAL. THE PROCEDURE TREATED A 70% STENOSIS IN THE FIRST OBTUSE MARGINAL AND A 70% STENOSIS IN THE FIRST DIAGONAL BRANCH. A 70% STENOSIS IN THE DISTAL LAD WAS ALSO TREATED WITH AN FIREBIRD DES. POST-PROCEDURE STENOSIS WAS 20%. THE REPORT IS FROM THE STUDY. THE PT WAS A MALE WITH 3 VESSEL DISEASE AND A FAMILY HISTORY OF CORONARY ARTERY DISEASE. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE 1ST TARGET LESION WAS THE PROXIMAL RCA. THE VESSEL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 20 MM. PRE-PROCEDURE STENOSIS WAS 85%. THE LESION WAS DE NOVO AND CONCENTRIC. THE LESION WAS NOT PRE-DILATED. A CYPHER DEPLOYED AT 16 ATM AND WAS POST-DILATED BECAUSE IT WAS NOT FULLY EXPANDED. POST-DILATION WAS CONDUCTED WITH A 4 X 13MM BALLOON AT 22 ATM. POST-PROCEDURE STENOSIS WAS 0%. THE 2ND TARGET LESION WAS THE MID TO DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VESSEL DIAMETER WAS 2.75MM AND THE LESION LENGTH WAS 50MM. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS DE NOVO, IRREGULAR CONTOUR AND CONCENTRIC. THE LESION WAS NOT PRE-DILATED. A CYPHER WAS DEPLOYED AT 16 ATM AND POST-DILATED BECAUSE THE STENT WAS NOT FULLY EXPANDED. POST-DILATION WAS CONDUCTED WITH A 3 X 13MM BALLOON AT 18 ATM. A CYPHER WAS DEPLOYED AT 18 ATM AND POST-DILATED BECAUSE THE STENT WAS NOT FULLY EXPANDED. POST-DILATION WAS CONDUCTED WITH A 3 X 13MM BALLOON AT 16 ATM. POST-PROCEDURE STENOSIS WAS 0%. A CYPHER. POST-PROCEDURE STENOSIS WAS 0%. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PT WAS DISCHARGED 4 DAYS POST-PROCEDURE.

    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 13180993

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention MEDICATIONS: ACE INHIBITORS| ASPIRIN| BETA BLOCKERS| CLOPIDOGREL| HEPARIN| STATINS