BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1140110 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02116
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    December 21, 2006
    Report Date
    July 24, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE STUDY: DURING THE INDEX PROCEDURE, THE PATIENT'S CK WAS 7.33 AND THE TROPONIN WAS 206. DURING THE INDEX PROCEDURE, THE PATIENT UNDERWENT A (PCI) PERCUTANEOUS CORONARY INTERVENTION OF THE MIDDLE RIGHT CORONARY ARTERY. THE VESSEL VISUAL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 13MM. THE LESION WAS TYPE B2, IRREGULAR CONTOUR, READILY ACCESSIBLE PROXIMAL SEGMENT, WITH NONE TO LITTLE CALCIFICATION, DISCRETE, WITH AN OCCLUSION THAN TOTAL, AND ECCENTRIC. THE VESSEL WAS TREATED WITH DIRECT STENTING WITH A CYPHER STENT. ADDITIONALLY, THREE UNKNOWN GUIDING CATHETERS WERE UTILIZED DURING THE PROCEDURE. THE PRE-PROCEDURE TIMI FLOW WAS ZERO AND AFTER STENTING, IT WAS THREE. THE MEDICATION GIVEN DURING THE PROCEDURE CONSISTED OF CLOPIDOGREL, ASPIRIN, AND HEPARIN. DURING HOSPITAL STAY THE PATIENT RECEIVED CLOPIDOGREL, ASPIRIN, STATINS, BETA-BLOCKERS, ACE INHIBITORS, AND HEPARIN. DURING THE STAGED PROCEDURE CONDUCTED A FOUR DAYS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT A (PCI) PERCUTANEOUS CORONARY INTERVENTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE VESSEL VISUAL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 20MM. THE LESION WAS TYPE B2, IRREGULAR CONTOUR, READILY ACCESSIBLE PROXIMAL SEGMENT AND ECCENTRIC. THE VESSEL WAS TREATED WITH DIRECT STENTING WITH A CYPHER STENT. THE PRE/POST PROCEDURE TIMI FLOW WAS THREE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANGINA OR SILENT ISCHEMIA, AND AN ELECTROCARDIOGRAM WAS CONDUCTED. THE ONE-MONTH FOLLOW-UP CONDUCTED VIA TELEPHONE INDICATED THAT THE PATIENT HAD NO ANGINA OR SILENT ISCHEMIA, AND THE MEDICATIONS CONSISTED OF CLOPIDOGREL, ASPIRIN, STATINS, BETA-BLOCKERS, AND ACE INHIBITORS. THE REPORT FROM TYPHOON INDICATED THAT THE PATIENT HAD AN UNSCHEDULED OFFICE VISIT IN WHICH THE PATIENT HAD NO ANGINA OR SILENT ISCHEMIA, AND THE MEDICATIONS CONSISTED OF CLOPIDOGREL, ASPIRIN, STATINS, BETA-BLOCKERS, AND ACE INHIBITORS. THE SIX-MONTH FOLLOW-UP CONDUCTED VIA TELEPHONE INDICATED THAT THE PATIENT HAD NO ANGINA OR SILENT ISCHEMIA, AND THE MEDICATIONS CONSISTED OF CLOPIDOGREL, ASPIRIN, STATINS, BETA-BLOCKERS, AND ACE INHIBITORS. THE EIGHT-MONTH FOLLOW-UP CONDUCTED VIA OFFICE VISIT INDICATED THAT THE PATIENT HAD NO ANGINA OR SILENT ISCHEMIA, AND THE MEDICATIONS CONSISTED OF CLOPIDOGREL, ASPIRIN, STATINS, BETA-BLOCKERS, AND ACE INHIBITORS. THE TWELVE-MONTH FOLLOW-UP CONDUCTED VIA TELEPHONE WITH PATIENT/RELATIVE INDICATED THAT THE PATIENT HAD NO ANGINA OR SILENT ISCHEMIA, AND THE MEDICATIONS CONSISTED OF CLOPIDOGREL, ASPIRIN, STATINS, BETA-BLOCKERS, AND ACE INHIBITORS. THIS PRODUCT (CRS) IS SIMILAR TO US CYPHER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    PER THE STUDY: THIS MALE PATIENT WITH A BMI OF 29, WITH A MEDICAL HISTORY OF SMOKING WAS CONSENTED FOR THE STUDY. APPROXIMATELY THREE YEARS AFTER THE INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED WITH ATYPICAL CHEST PAIN WHILE DRIVING HIS CAR. A CONTROLLED ANGIOGRAPHY SHOWED NO STENT RESTENOSIS, THE (LVEF) LEFT VENTRICULAR EJECTION FRACTION WAS 70%, AND A 70% STENOSIS ON THE FIRST DIAGONAL BRANCH. THE TREATMENT CONDUCTED CONSISTED OF STOPPING OF PLAVIX AND ADDING SOPROL 20MG. THE EVENT WAS CONSIDERED UNLIKELY RELATED TO THE DEVICE AND PROCEDURE. THE INITIAL REPORT INDICATED THAT ONLY THE MIDDLE RIGHT CORONARY ARTERY WAS INVOLVED. HOWEVER, AFTER OBTAINING ADDITIONAL INFORMATION, IT WAS NOTED THAT THE PATIENT RECEIVED A CYPHER STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY.

    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 I0803030

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening UNKNOWN GUIDING CATHETER