BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1034319 · Received April 24, 2008

    Report

    Report Number
    9616099-2008-01082
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 3-VESSEL DISEASE WAS FOUND. ONE LESION WAS TREATED DURING THE INDEX AND A STAGED PROCEDURE WAS NOT PLANNED. THE PRIMARY INDICATION FOR INTERVENTION WAS STABLE ANGINA PECTORIS. PRE-PROCEDURE CK AND CK-MB WERE WITHIN NORMAL LIMITS. THE PATIENT'S BLOOD PRESSURE AT THE BEGINNING OF THE PROCEDURE WAS 130/80 AND THE HEART RATE WAS 76. THE LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS NOT AVAILABLE. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND UNFRACTIONATED HEPARIN. PCI WAS PERFORMED ON A 99% DE NOVO LESION IN THE MID CIRCUMFLEX OF 30 MM IN LENGTH IN A 3.0 MM VESSEL DIAMETER. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED WITH AN IRREGULAR CONTOUR, MODERATE CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.5 X 30 MM BALLOON AT 10 ATMOSPHERES (ATM) BEFORE 3.0 X 13MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 14 ATM WITH SATISFACTORY RESULTS. THERE WAS NO POST-DILATATION. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. THERE WERE NO PROCEDURAL COMPLICATIONS. AT THE 6-24 HOUR INTERVAL POST-PROCEDURE, CK AND CK-MB WERE WITHIN NORMAL LIMITS. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 12 MONTHS, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. AT THE 1 AND 6-MONTH FOLLOW-UP INTERVALS, THE PATIENT HAD ANGINA PECTORIS. POST-PROCEDURE MEDICATIONS REMAINED UNCHANGED AND THERE WERE NO ADVERSE EVENTS REPORTED. AT THE 1-YEAR FOLLOW-UP INTERVAL, THE PATIENT WAS ASYMPTOMATIC. POST-PROCEDURE MEDICATIONS REMAINED UNCHANGED AND THERE WERE NO ADVERSE EVENTS REPORTED. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED PRODUCT. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, 27 1/2 MONTHS AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT HAD A Q-WAVE MI WITH AN UNDETERMINED LOCATION. CK AND TROPONIN WERE LESS THAN TWO TIMES ABOVE THE UPPER NORMAL LIMITS. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. IT DID NOT REQUIRE CABG BUT DID REQUIRE RE PCI. THE PATIENT WAS ALSO ADMITTED THE LOCAL HOSPITAL WITH SHORTNESS OF BREATH ON MINIMAL EXERTION AND CHEST PAIN WHICH WAS RELIEVED BY NITROGLYCERIN SUBLINGUAL. PEAK VALUES FOR CARDIAC ENZYMES WERE CPK 253 AND TROPONIN I 0.59. ECG SHOWED ST SEGMENT DEPRESSION OF 1.5 MM IN D1, D2, V4, V6 LEADS. SHE WAS TRANSFERRED TO THE STUDY SITE UNDER DIAGNOSIS OF A NON Q-WAVE ACUTE MYOCARDIAL INFARCTION. TREATMENT PROVIDED WAS NOT DOCUMENTED. TWO WEEKS LATER, THE PT HAD ANGINA PECTORIS AND DIAGNOSTIC CORONARY ANGIOGRAPHY PERFORMED AFTER ADMISSION TO THE HOSPITAL SHOWED SIGNIFICANT FOCAL IN-STENT RESTENOSIS (80%) IN PROXIMAL SEGMENT OF PREVIOUSLY IMPLANTED CYPHER STENT. DIRECT STENTING OF THAT LESION WITH DRIVER BMS 3.0 X 12 MM STENT WAS PERFORMED, AND FINAL ANGIOGRAM SHOWED NO RESIDUAL STENOSIS IN THAT SEGMENT.

    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 I0906084

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R STATINS| CLOPIDOGREL| UNFRACTIONATED HEPARIN| BETA-BLOCKERS| CLOPIDOGREL| POST-ASPIRIN| INTRA-ASPIRIN| BETA-BLOCKERS| CLOPIDOGREL| DEVICES: DRIVER BMS 3.0X12 MM| STATINS| ACE INHIBITORS| MEDICATIONS: PRE-PROCEDURE: ASPIRIN| ACE INHIBITORS