BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001523 · Received February 20, 2008

    Report

    Report Number
    9616099-2008-00399
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    September 3, 2007
    Report Date
    January 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PCI WAS PERFORMED ON AN 80% DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX OF 9MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. THE (B1) ECCENTRIC LESION WAS CHARACTERIZED WITH AN IRREGULAR CONTOUR, LOCATED IN A SEVERE BENT POINT GREATER THAN 90 DEGREES, LITTLE TO NO CALCIFICATION AND THROMBUS PRESENT. THROMBUS ASPIRATION WAS NOT DONE. THE LESION WAS PRE-DILATED WITH A 2.5X9MM BALLOON AT 12 ATMOSPHERES (ATM) BEFORE A 3.0X33MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 14 ATM WITH SATISFACTORY RESULTS. THERE WAS NO POST-DILATATION. FOLLOWING THE DEPLOYMENT, THERE WAS NO REFLOW. ADENOSINE AND SODIUM NITROPRUSSIDE WERE USED. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III ACHIEVED AT THE END OF THE PCI. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III FLOW WAS ALSO RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. IN ADDITION, A HEMATOMA FORMED AT THE SHEATH INSERTION SITE POST-PROCEDURE. THE PATIENT HAD VASOVAGAL IN THE WARD WHEN THE HEMATOMA WAS COMPRESSED. FLUIDS, PAIN RELIEF AND BLOOD TRANSFUSION FOR LOW HEMOGLOBIN WERE REQUIRED. REOPRO WAS STOPPED. THE PATIENT RECOVERED POST INFUSIONS. THE PATIENT HAD AN ANGIOSEAL DEVICE INSERTED IN THE LAB FOR HOMEOSTASIS. POST-PROCEDURE CK WAS LESS THAN TWO TIMES ABOVE THE UPPER NORMAL LIMITS AT THE 6-24 HOUR INTERVAL. NO FURTHER ENZYME CHECKS WERE MADE. THE PATIENT WAS DISCHARGED TWO DAYS LATER. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, PERMANENT CLOPIDOGREL AND STATINS. TELEPHONE FOLLOW-UP WAS MADE WITH THE PATIENT 56 DAYS LATER, AT THE 1-MONTH FOLLOW-UP INTERVAL. THE PATIENT WAS ASYMPTOMATIC. ONGOING MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND STATINS. 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 DEVICE. 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, FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI), THERE WAS NO REFLOW POST STENT IMPLANTATION. ADENOSINE AND SODIUM NITROPRUSSIDE WERE USED. THE PRIMARY INDICATION FOR INTERVENTION WAS AN ACUTE NON ST ELEVATION MYOCARDIAL INFARCTION WITHIN 72 HOURS OF ADMISSION AND WITH AN UNDETERMINED LOCATION. THE LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS NOT AVAILABLE. THE PATIENT'S BLOOD PRESSURE WAS 170/90 AND THE HEART RATE WAS 53. PRE-PROCEDURE CARDIAC ENZYMES WERE AS FOLLOWS: CK WAS WITHIN NORMAL LIMITS, CK-MB WAS NOT CHECKED AND TROPONIN WAS FOUR TIMES ABOVE UPPER NORMAL LIMITS. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, ACE INHIBITORS AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED REOPRO AND LOW MOLECULAR WEIGHT 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 13197445

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R INTRA-PROCEDURE MEDICATIONS INCLUDED REOPRO| LOW MOLECULAR WEIGHT HEPARIN| POST-PERMANENT ASPIRIN| PERMANENT CLOPIDOGREL| STATINS