BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032756 · Received April 22, 2008

    Report

    Report Number
    9616099-2008-01072
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    January 28, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PCI WAS PERFORMED ON A LESION IN THE MID CIRCUMFLEX OF 90MM IN LENGTH IN A 2.5MM VESSEL DIAMETER WITH MODERATE TORTUOSITY OF THE PROXIMAL SEGMENT. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, ANGULATION BETWEEN 45-90 DEGREES, MODERATE CALCIFICATION AND THROMBUS ABSENT. TWO STENTS WERE DEPLOYED BY DIRECT STENTING WITH A GAP. A 2.5X8MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 20 ATMOSPHERES (ATM) WITH SATISFACTORY RESULTS. THERE WAS NO POST-DILATATION. THEN A SECOND 2.5X8MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 20 ATM WITH SATISFACTORY RESULTS. THERE WAS NO POST-DILATATION. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. POST-PROCEDURE CK, CK-MB AND TROPONIN WERE WITHIN NORMAL LIMITS BOTH AT THE 6-24 HOUR INTERVAL AND THE 24-HOUR INTERVAL TO DISCHARGE. THERE WERE NO PROCEDURAL COMPLICATIONS AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 6 MONTHS, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. AT THE 1-MONTH FOLLOW-UP INTERVAL, THE PATIENT WAS ASYMPTOMATIC. ONGOING MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. THE PREVIOUSLY NOTED ADVERSE EVENTS WERE DOCUMENTED. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. 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, THREE DAYS AFTER DISCHARGE, THE PATIENT WAS REHOSPITALIZED BECAUSE OF RECURRENT ANGINA (CCS IV). CARDIAC ENZYMES WERE ABOVE THE UPPER NORMAL LIMITS THAT WERE CLASSIFIED AS AN INFERIOR WALL NON-Q-WAVE MYOCARDIAL INFARCTION THAT WAS TARGET VESSEL RELATED. CK, CK-MB AND TROPONIN WERE GREATER THAN OR EQUAL TO FIVE TIMES ABOVE THE UPPER NORMAL LIMITS. CORONARY ANGIOGRAPHY SHOWED TOTAL OCCLUSION AND IN-STENT THROMBOSIS OF THE DISTAL LEFT CIRCUMFLEX. TREATMENT INVOLVED A REPEAT PCI, STENTING WITH A 2.75X13MM CYPHER SELECT PLUS STENT AND INTRAVENOUS REOPRO. ATRIAL FIBRILLATION WAS TREATED WITH AMIDORAN AND ELECTRIC CARDIOVERSION. THIS WAS LISTED AS HIGHLY PROBABLY RELATED TO THE STENT. ASPIRIN AND CLOPIDOGREL WERE ONGOING AT THE TIME OF THESE EVENTS. THE PATIENT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 3-VESSEL DISEASE WAS ALSO FOUND. THE PRIMARY INDICATION FOR INTERVENTION WAS UNSTABLE ANGINA PECTORIS (TROPONIN NEGATIVE OR UNKNOWN). THE PATIENT'S BLOOD PRESSURE AT THE BEGINNING OF THE PROCEDURE WAS 144/86 AND THE HEART RATE WAS 70. THE LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS 30-50%. PRE-PROCEDURE CK, CK-MB AND TROPONIN WERE WITHIN NORMAL LIMITS. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND UNFRACTIONATED HEPARIN.

    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 13325491

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R ACE INHIBITORS| POST-PERMANENT ASPIRIN| BETA-BLOCKERS| STATINS| ACE INHIBITORS| UNFRACTIONATED HEPARIN| CLOPIDOGREL FOR 6 MONTHS| MEDICATIONS: PRE-ASPIRIN| STATINS| BETA-BLOCKERS| INRA-ASPIRIN| CLOPIDOGREL