BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001562 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00388
    Event Type
    Other
    Date Received
    February 19, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 28, 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

    ALSO REPORTED FOR THIS PATIENT: SIX DAYS POST INDEX PROCEDURE (2007) THE PATIENT WAS ADMITTED WITH 30 MINUTES CENTRAL CHEST PAIN. CK WAS NORMAL, AND AN ELEVATED TROPONIN AT 4 TIMES ABOVE UPPER NORMAL LEVELS. ECHOCARDIOGRAM SHOWED PACED RHYTHM. CORONARY ANGIOGRAM SHOWED A PATENT CYPHER STENT IN THE LAD AND NO NEW LESIONS. THE PATIENT WAS DIAGNOSED WITH A NON-Q WAVE MYOCARDIAL INFARCTION. THE LOCATION OF THE MI WAS UNDETERMINED. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. THE EVENT WAS MEDICALLY MANAGED AND RE-PCI WAS NOT REQUIRED. THIS EVENT WAS REPORTED AS UNLIKELY RELATED TO THE INDEX PROCEDURE AND DEVICE. AT ONE MONTH FOLLOW-UP, THE PATIENT REPORTED ANGINA PECTORIS (2008). THE PATIENT WAS COMPLIANT WITH ANTIPLATELET REGIMEN. IN 2007, THE PATIENT REPORTED A VASO-VAGAL EPISODE/(SYNCOPE-FAINTING) AFTER STRAINING DURING A BOWEL MOVEMENT. THIS EVENT WAS REPORTED AS UNRELATED TO THE INDEX DEVICE AND UNLIKELY RELATED TO THE INDEX PROCEDURE. ALSO REPORTED ON THIS DATE WAS ANGINA PECTORIS/CENTRAL CHEST PAIN RELIEVED WITH S/1 GLYCERYL TRINITRATE (GTN). THIS EVENT WAS RELATED AS POSSIBLY RELATED TO THE INDEX DEVICE AND PROCEDURE. THE PATIENT WAS RANDOMIZED TO THE CLINICAL STUDY FOR ONE-VESSEL DISEASE ONE DAY BEFORE. A STAGED PROCEDURE WAS NOT PLANNED. THE INDICATION FOR THE INDEX PROCEDURE WAS AN ANTERIOR ACUTE MYOCARDIAL INFARCTION >72H PRE-PROCEDURE. THE PATIENT'S MEDICAL HISTORY CONSISTS OF PREVIOUS PERCUTANEOUS INTERVENTION, HYPERTENSION, AND HYPERLIPIDEMIA, PAST NICOTINE HABIT, HISTORY OF ALLERGY/HYPERSENSITIVITY, CONNECTIVE TISSUE DISORDER, MILD LIVER DISEASE, AND MODERATE TO SEVERE RENAL DISEASE. A BASELINE AND POST PROCEDURE ECG WAS PERFORMED. BASELINE HEART RATE WAS 75/MIN, BLOOD PRESSURE WAS 120/60 AND LEFT VENTRICULAR EJECTION FRACTION WAS >50%. PRE PROCEDURE CARDIAC ENZYMES ARE UNKNOWN AND POST PROCEDURE CARDIAC ENZYMES WERE ELEVATED; TROPONIN WAS <2 ABOVE UPPER NORMAL LEVELS. THE TARGET LESION WAS AT THE MID LAD. REFERENCE VESSEL DIAMETER WAS 3.0MM AND LESION LENGTH WAS 15MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 80%, AND POST PROCEDURE WAS ZERO PERCENT. TIMI FLOW PRE AND POST PROCEDURE WAS III. THE LESION WAS DENOVO, SMOOTH AND READILY ACCESSIBLE AT PROXIMAL SEGMENT. ANGULATION WAS <45 DEGREES, ECCENTRIC, WITH LITTLE TO NO CALCIFICATION AND WITHOUT THROMBUS. LESION CLASSIFICATION WAS TYPE B1. A 6F - GUIDING CATHETER WAS USED. THE LESION WAS PRE-DILATED WITH A 2.5X14MM BALLOON AT 14 ATM. A CRB1830 WAS DEPLOYED AT 14 ATMS WITH SATISFACTORY RESULTS. POST DILATATION WAS PERFORMED WITH A 2.5X10MM BALLOON AT 12 ATMS DUE TO STENT UNDER EXPANSION. IVUS WAS NOT CONDUCTED. THE PATIENT WAS DISCHARGED ON 100MG ASPIRIN, STATINS, LIPID LOWERING DRUGS, ACE-INHIBITORS, BETA-BLOCKERS AND 75MG CLOPIDOGREL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. PLEASE NOTE: DEVICE (LOT# 13242748) IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS RECEIVED FROM THE REGISTRY FOR THIS PATIENT: IN 2008, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ISCHEMIC CEREBRAL VASCULAR ACCIDENT (CVA; EMBOLIC STROKE. AT APPROX 10 DAYS LATER, THE PATIENT EXPIRED. THE DEATH WAS REPORTED AS NON-CARDIAC AND THE CAUSE PROVIDED WAS CEREBRAL VASCULAR ACCIDENT (CVA). THERE WAS NO EVIDENCE OF THROMBUS. AN AUTOPSY WAS NOT PERFORMED. THIS EVENT WAS REPORTED AS UNLIKELY RELATED TO THE INDEX DEVICE AND UNRELATED TO THE INDEX PROCEDURE.

    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 13242748

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H