BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1213834 · Received October 28, 2008

    Report

    Report Number
    9616099-2008-02552
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    November 23, 2007
    Report Date
    October 6, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBERS ARE 9616099-2008-02551, AND 9616099-2008-02553. THIS MALE IN THE REGISTRY EXPERIENCED ELEVATED CARDIAC ENZYMES POST IMPLANTATION OF 3 CYPHER SELECT + STENTS. MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA AND ACTIVE SMOKING. DURING THE INDEX PROCEDURE, ONE 3.5X18MM STENT WAS IMPLANTED IN THE PROXIMAL-TO-MID LAD, ONE 3.0X8MM STENT WAS IMPLANTED IN THE DISTAL LAD, AND ONE 3.5X13MM STENT WAS IMPLANTED IN THE DISTAL RCA. THE TARGET SITE IN THE LAD WAS DESCRIBED AS A TYPE B2 LESION; AT A BIFURCATION REQUIRING DOUBLE GUIDEWIRES, MODERATELY CALCIFIED WITH 16MM LESION LENGTH AND 90% STENOSIS. THE 3.5X18MM STENT WAS DEPLOYED AT 11 ATM; NO POST-DILATATION WAS DONE; TIMI II FLOW RETURNED TO TIMI III FLOW. THE TARGET SITE IN THE DISTAL LAD WAS ALSO DESCRIBED AS TYPE B2 LESION: 6MM LESION LENGTH WITH 75% STENOSIS. THE 3.0/8MM STENT WAS DEPLOYED AT 14ATM WITH A GOOD RESULT. NO POST-DILATATION WAS DONE AND TIMI III FLOW WAS MAINTAINED. THE TARGET SITE IN THE RCA WAS DESCRIBED AS A TYPE B1 LESION: IRREGULAR CONTOUR WITH 10MM LESION LENGTH AND 90% STENOSIS. THE STENT WAS IMPLANTED AT 13 ATM. NO POST-DILATATION WAS DONE; TIMI II FLOW RETURNED TO TIMI III FLOW. NO COMPLICATIONS WERE REPORTED. POST-PROCEDURE CK-MB AND TROPONIN (24H TO DISCHARGE) WERE 4X AND 5X (RESPECTIVELY) ABOVE THE ULN. PRE-PROCEDURE CARDIAC ENZYMES WERE NOT PROVIDED. THE PT WAS DISCHARGED ON ASA, PLAVIX, ACE-INHIBITORS, STATINS AND BETA-BLOCKERS. AT THE 1-MONTH FOLLOW-UP, THE PT REMAINED ASYMPTOMATIC BUT WAS EXPERIENCING ANGINA AT THE 6-MONTH FOLLOW-UP. APPROX 7 MOS POST-PROCEDURE, HE UNDERWENT STENTING OF THE PROXIMAL CIRCUMFLEX. THIS HAD BEEN PLANNED AT THE INDEX PROCEDURE. NO RE-OCCLUSION OF THE PREVIOUSLY STENTED SEGMENTS WERE REPORTED. NO PRODUCTS COULD BE RETURNED; THEY REMAINED IMPLANTED. A REVIEW OF THE MFG RECORDS INDICATED THAT THESE PRODUCTS MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT POST PROCEDURE (24 HOURS-DISCHARGE) PEAK CK-MB LEVELS WERE FOUR TIMES ABOVE THE UPPER NORMAL LEVEL AND POST PROCEDURE (24HOURS-DISCHARGE) TROPONIN LEVELS WERE GREATER THAN OR EQUAL TO FIVE TIMES ABOVE THE UPPER NORMAL LEVEL. ONE HUNDRED AND NINETY DAYS POST INDEX PROCEDURE, THE PT HAD A PLANNED STAGED PROCEDURE DONE TO TREAT A 90% LESION IN THE PROXIMAL CIRCUMFLEX. IT WAS NOTED THAT THE PT HAD BEEN EXPERIENCING CHEST PAIN. THIS PROCEDURE WAS PLANNED AND WAS DEEMED TO BE UNRELATED TO ANY CORDIS PRODUCT. THE PT WAS INITIALLY ENROLLED IN THE STUDY IN 2007 WITH 3-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS UNSTABLE ANGINA PECTORIS. THE FIRST LESION TREATED WAS IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING BRANCH. THE LESION WAS 16MM IN LENGTH WITH 90% STENOSIS AND WAS DE NOVO, BIFURCATED, ECCENTRIC AND MODERATELY CALCIFIED. THE VESSEL WAS 3.5MM IN DIAMETER. THE LESION WAS PRE-DILATED AND A 3.5X18MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 11ATM. THE SECOND LESION TREATED WAS IN THE DISTAL ANTERIOR DESCENDING BRANCH. THE LESION WAS 6MM IN LENGTH WITH 75% STENOSIS WAS DE NOVO, SMOOTH AND CONCENTRIC. THE VESSEL WAS 3MM IN DIAMETER. A 3.0X8MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 14ATM. THE LESION WAS 10MM IN LENGTH WITH 90% STENOSIS AND WAS DE NOVO, IRREGULAR AND CONCENTRIC. THE VESSEL WAS 3.5MM IN DIAMETER. A 3.5X13MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 13ATM. THE PT'S BASELINE MEDICATIONS INCLUDED ASPIRIN, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. THE PT'S INTRA PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, AGGRASTAT AND HEPARIN. THE PT'S POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS.

    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 13287809

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization THE FOLLOWING PRODUCTS WERE USED DURING THE| A 6F GUIDING CATHETER| PROCEDURE: A CUTTING BALLOON| 3.0X6MM BALLOON CATHETER