BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1061320 · Received June 13, 2008

    Report

    Report Number
    9616099-2008-01508
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    October 9, 2007
    Report Date
    May 19, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 EVAL. ADDITIONAL INFO IS PENDING REGARDING THE ADVERSE EVENTS AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2008-01507 AND 9616099-2008-01508.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, THIS PT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 2-VESSEL DISEASE WAS FOUND. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITHOUT PROCEDURAL COMPLICATIONS. THE PCI WAS PERFORMED ON A LESION IN THE MID LAD AND A 2.5X13MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH SUB-OPTIMAL RESULTS. POST-DILATATION WAS CONDUCTED WITH A 3.0X15MM BALLOON AT 22 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED AND BECAUSE OF DISSECTION. THE DISSECTION TYPE IS NOT CURRENTLY KNOWN. THEN A 2.5X18MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH SUB-OPTIMAL RESULTS. POST-DILATATION WAS CONDUCTED WITH A 3.0X15MM BALLOON AT 22 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED, DISSECTION AND INSUFFICIENT FLOW. AGAIN, THE DISSECTION TYPE IS NOT CURRENTLY KNOWN. THEN A 2.75X23MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITHOUT SATISFYING RESULTS. THERE WAS NO POST-DILATATION. THE PT WAS DISCHARGED ON THE SAME DAY OF THE PROCEDURE. THIS PT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 2-VESSEL DISEASE WAS FOUND. TWO LESIONS WERE TREATED DURING THE PROCEDURE. THE PRIMARY INDICATION FOR INTERVENTION WAS STABLE ANGINA PECTORIS. PRE-PROCEDURE CK, CK-MB AND TROPONIN WERE WITHIN NORMAL LIMITS. THE PATIENT'S BLOOD PRESSURE AT THE BEGINNING OF THE PROCEDURE WAS 130/90 AND THE HEART RATE WAS 54. LEFT VENTRICULAR EJECTION FRACTION (LVEF) WAS NOT AVAILABLE. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS AND ACE INHIBITORS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. PCI WAS PERFORMED ON AN 85% DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (RCA) OF 20MM IN LENGTH IN A 2.75MM VESSEL DIAMETER. THE (B2) CONCENTRIC LESION WAS CHARACTERIZED WITH AN IRREGULAR CONTOUR, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.0X12MM BALLOON AT 16A ATMOSPHERES (ATM) BEFORE TWO OVERLAPPING STENTS WERE DEPLOYED. A 2.75X13MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH SUB-OPTIMAL RESULTS. POST-DILATION WAS CONDUCTED WITH A 3.0X8MM BALLOON AT 22 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED. THEN ANOTHER 2.75X13MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH SUB-OPTIMAL RESULTS. POST-DILATION WAS CONDUCTED WITH A 3.0X8MM BALLOON AT 22 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. THERE WERE NO PROCEDURAL COMPLICATIONS. PCI WAS PERFORMED NEXT ON AN 80% DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) OF 50MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, ANGULATION BETWEEN 45 TO 90 DEGREES, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. A 2.5X13MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH SUB-OPTIMAL RESULTS. POST-DILATION WAS CONDUCTED WITH A 3.0X15MM BALLOON AT 22 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED AND DUE TO A DISSECTION. THE DISSECTION TYPE IS NOT CURRENT KNOWN BUT HAS BEEN REQUESTED. THEN A 2.5X18MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH SUB-OPTIMAL RESULTS. POST-DILATION WAS CONDUCTED WITH A 3.0X15MM BALLOON AT 22 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED, INSUFFICIENT FLOW AND A DISSECTION. FINALLY, A 2.75MM X 23MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITHOUT SATISFYING RESULTS. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. POST-PROCEDURE CARDIAC ENZYMES WERE NOT DOCUMENTED AND THE PT WAS DISCHARGED ON THE SAME DAY. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 12 MONTHS, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. DURING THE 1-MONTH FOLLOW-UP INTERVAL, THE PT WAS ASYMPTOMATIC FOR ANGINA SYMPTOMS. ONGOING MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. NO NEW ADVERSE EVENTS WERE REPORTED. DURING THE 6-MONTH TELEPHONE FOLLOW-UP INTERVAL, THE PT WAS ASYMPTOMATIC FOR ANGINA SYMPTOMS. ONGOING MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. NO NEW ADVERSE EVENTS WERE REPORTED. SIX MONTHS LATER, THE PT HAD A REPEAT PCI THAT WAS CLINICALLY DRIVEN. ANGIOGRAPHY REVEALED 0% STENOSIS IN EACH OF THE PREVIOUSLY TREATED LESIONS, NO RESTENOSIS PATTERN, NO PER-STENT STENOSIS, NO ANEURYSM AT THE TREATED SITE AND TIMI III FLOW. A LESION IN THE PROXIMAL CIRCUMFLEX WITH 90% STENOSIS WAS TREATED WITH AN UNKNOWN STENT. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%.

    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 13240730

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN| ACE INHIBITORS| POST-ASPIRIN| CLOPIDOGREL| PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN| STATINS| CLOPIDOGREL| ACE INHIBITORS| CLOPIDOGREL| STATINS| BETA-BLOCKERS.