BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021276 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00789
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    April 23, 2007
    Report Date
    February 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYPHER SELECT PROD IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PROD. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS MALE PT WITH A HISTORY OF PREVIOUS PCI (TARGET VESSEL/NON-TARGET LESION PREVIOUSLY TREATED IN 2007), AND HYPERLIPIDEMIA WAS ADMITTED FOR CORONARY EVAL. HE WAS CURRENTLY TAKING ASPIRIN, PLAVIX, STATINS, ACE INHIBITORS, AND BETA-BLOCKERS. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. BASELINE ASSESSMENT REVEALED BRADYCARDIA (49 BPM) AND BORDERLINE HYPOTENSION (110/62 MMHG). ANGIOGRAPHY REVEALED A 70%, 10MM, DE NOVO, SMOOTH, CONCENTRIC, TYPE A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ADD'L LESION WAS NOTED IN THE FIRST DIAGONAL BRANCH. THIS WAS DESCRIBED AS AN 80%, 3MM DE NOVO, SMOOTH, ECCENTRIC, TYPE-A STENOSIS IN THE OSTIUM OF THE VESSEL. HEPARIN WAS ADMINISTERED. CLOTTING TIMES MEASURED DURING THE PROCEDURE WERE VASP 9% AND PFA-100 OF 144 SECONDS. NO ADD'L DOSES OF ASPIRIN OR A PLAVIX WERE ADMINISTERED. THE MID-LAD LESION WAS NOT PREDILATED. A 2.5 X 18MM CYPHER SELECT STENT WAS DEPLOYED TO 24 ATMS WITH GOOD RESULTS. FOLLOWING IMPLANTATION OF THE FIRST CYPHER STENT IN THE MID-LAD, A DISTAL PLAQUE SHIFT WAS NOTED. TO TREAT THIS, AN ADD'L 2.5 X 08MM CYPHER SELECT STENT WAS PLACED ABUTTING TO THE FIRST AND WAS DEPLOYED TO 10 ATMS WITH SATISFACTORY RESULTS. THE DIAGONAL LESION WAS NOT PREDILATED. A 2.5 X 08MM CYPHER SELECT STENT WAS DEPLOYED TO 16 ATMS WITH GOOD RESULTS. THE STENTS WERE NOT POST DILATED. AT ONE-MONTH AND SIX-MONTH FOLLOW-UPS, THE PT WAS ASYMPTOMATIC AND WAS COMPLIANT WITH ALL CARDIAC MEDICATIONS.

    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 13173920

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention