BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161347 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02238
    Event Type
    Death
    Date Received
    September 12, 2008
    Date of Event
    July 28, 2008
    Report Date
    September 4, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET VESSEL WAS THE NATIVE RIGHT CORONARY ARTERY (RCA) SEGMENTS 1 AND 2. THE LESION WAS DESCRIBED AS 2.75MM VESSEL DIAMETER, 52MM LESION LENGTH, AND 95% STENOSIS (ALL VISUALLY ESTIMATED). PRE-PROCEDURE THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW GRADE WAS NOT INDICATED. LESION CHARACTERISTICS WERE DESCRIBED AS DE NOVO, TYPE C, TOTALLY OCCLUDED, CONCENTRIC, NON-BIFURCATED, NON-OSTIAL WITH IRREGULAR CONTOUR AND READILY ACCESSIBLE PROXIMAL SEGMENT. THERE WAS NO ANGULATION AND LITTLE TO NO CALCIFICATION. NO THROMBUS WAS PRESENT. THE LESION WAS PRE-DILATED WITH A 2.0 X 20 BALLOON CATHETER AT 12 ATMOSPHERES MAXIMUM INFLATION PRESSURE AND TWO CYPHER SELECT PLUS STENTS WERE DEPLOYED IN AN OVERLAPPING FASHION. THE FIRST 2.75 X 33MM STENT WAS DEPLOYED AT 14 ATMOSPHERES MAXIMUM PRESSURE, AND THE SECOND 2.75 X 28MM STENT WAS DEPLOYED AT 20 ATMOSPHERES MAXIMUM INFLATION BOTH WITH SATISFACTORY RESULTS. THERE WAS NO POST-DILATATION OF THE STENTS, AND INTRAVASCULAR ULTRASOUND, THROMBUS ASPIRATION, OR DISTAL PROTECTION DEVICE WAS NOT COMPLETED DURING IMPLANTATION OF THESE STENTS. THERE WERE NO COMPLICATIONS OR DEVICE DEVIATION DURING THE PROCEDURE. VISUALLY ESTIMATED POSTPROCEDURE STENOSIS WAS 0%. HOWEVER, NO POST-PROCEDURE TIMI FLOW GRADE WAS INDICATED. AFTER PROCEDURE, BEFORE DISCHARGE MEDICATIONS DIRECTED WERE ASPIRIN DAILY DOSE 160MG AND CLOPIDOGREL DAILY DOSE 75MG. THE PATIENT WAS DISCHARGED 2007 ON ASPIRIN DAILY DOSE 100MG PERMANENT REGIMEN, CLOPIDOGREL DAILY DOSE 75MG FOR 12 MONTHS, INSULIN, AND BETA BLOCKERS. THE DAY OF THE INDEX PROCEDURE, THE PATIENT HAD A SEMI-OCCLUSION SHEATH, WHICH CAUSED A RIGHT "COLD LEG". THIS WAS RESOLVED AFTER SHEATH REMOVAL. A 6F MEDTRONIC SHEATH WAS USED. THIS EVENT WAS GRADED AS MODERATE IN SEVERITY AND WAS REPORTED TO BE UNRELATED TO THE DEVICE AND HIGHLY PROBABLE TO THE PROCEDURE. THE EVENT WAS RESOLVED WITHOUT SEQUEL. APPROXIMATELY 20 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED ACUTE PAIN TO RIGHT HEEL WITH RISE OF CRP, WHICH REQUIRED INPATIENT HOSPITALIZATION AND MEDICAL/SURGICAL TREATMENT TO PREVENT A PERMANENT IMPAIRMENT. THE PATIENT WAS HOSPITALIZED FOR CO2 ANGIOGRAPHY. A SIGNIFICANT STENOSIS WAS FOUND IN THE LEFT ARTERIA FEMORALIS SUPERFICIALIS. A SUCCESSFUL BALLOON DILATATION WITH STENT IMPLANTATION WAS PERFORMED OF THE ABOVE LESION. ALSO BALLOON DILATATION OF THE STENOSIS IN THE RIGHT ARTERIA ILIACA EXTERNA WAS COMPLETED. THIS EVENT SEVERITY WAS GRADED AS SEVERE AND THE RELATIONSHIP TO THE STUDY DEVICES (CYPHER SELECT PLUS STENTS) OR ANY OTHER CORDIS DEVICES AND INDEX PROCEDURE WAS DETERMINED UNRELATED. TWO MONTHS LATER THE PATIENT WAS ADMITTED OT THE HOSPITAL WITH "BLACK TOE." THE PATIENT HAD IV AND CELLULITES OF THE RIGHT FOOT. ANGIOGRAPHY SHOWED A STENOSIS AND A SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS DONE. THE PATIENT HAD INCREASED OF PAIN AND NECROSIS. THREE WEEKS LATER THE PATIENT'S RIGHT LOWER LIMB WAS AMPUTATED. DURING THE SAME HOSPITALIZATION THE PATIENT DEVELOPED HEMATEMESIS WITH LOW TENSIONS AND HYPOVOLEMIC SHOCK TREATED WITH BLOOD TRANSFUSIONS AND VOLUVEN. AN URGENT GASTROSCOPY SHOWED REFLEX ESOFAGITIS, GRADE D AND ADRENALINE WAS INJECTED. PPI WERE STARTED AND PLAVIX AND ASPIRIN WERE TEMPORARILY STOPPED. THIS EVENT WAS GRADED AS SEVERE AND WAS REPORTED TO BE UNRELATED TO THE DEVICE AND UNRELATED TO THE INDEX PROCEDURE. THE EVENT WAS RESOLVED WITH SEQUELS. A MONTH LATER THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH ACUTE MELAENA AND HYPOTENSION. THE PATIENT ALSO HAD HYPOVOLEMIC SHOCK DUE TO A GASTRO-INTESTINAL BLEEDING WITH A HEMOGLOBIN DROP TO 4 G/DL. THE BLEEDING LESION IN THE BULBUS WAS TREATED WITH 12ML OF ADRENALINE. THIS EVENT WAS GRADED AS SEVERE AND WAS REPORTED TO BE UNRELATED TO THE DEVICE, AND UNRELATED TO THE INDEX PROCEDURE. THE EVENT WAS RESOLVED WITH SEQUELS. TEN DAYS LATER THE PATIENT HAD A MELAENA AND WAS TRANSFERED TO A DIFFERENT FACILITY. NO ACTIVE BLEEDING. THE PATIENT'S HEMOGLOBIN UPON ADMISSION WAS 6.1 G/DL, 3U PC WAS GIVEN. THIS EVENT WAS GRADED AS SEVERE AND WAS REPORTED TO BE UNRELATED TO THE DEVICE, AND UNRELATED TO THE INDEX PROCEDURE. THE EVENT WAS RESOLVED WITH SEQUELS. THREE MONTHS LATER THE PATIENT WAS HOSPITALIZED FOR PROTHESISREVALIDATION POST TRANSTIBIAL AMPUTATION. THIS EVENT WAS GRADED AS MODERATE IN SEVERITY AND WAS REPORTED TO BE UNRELATED TO THE DEVICE, AND UNRELATED TO THE INDEX PROCEDURE. THE EVENT WAS GRADED AS MODERATE IN SEVERITY AND WAS REPORTED TO BE UNRELATED TO THE DEVICE, AND UNRELATED TO THE INDEX PROCEDURE. THE EVENT WAS RESOLVED WITHOUT SEQUELS. FOUR MONTHS LATER THE PATIENT EXPIRED. IT WAS NOTED THAT THE PATIENT WAS SUFFERING FROM SHORTNESS OF BREATH TWO DAYS PRIOR. THE PATIENT COLLAPSED AND WAS ALREADY DEAD UPON ARRIVAL TO THE HOSPITAL. NO AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH IS UNKNOWN. THE EVENT WAS EVALUATED AND DETERMINED TO BE PROBABLY RELATED TO THE CORDIS PRODUCT AND PROBABLY RELATED TO THE INDEX PROCEDURE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2008-02237.

    Description of Event or Problem · 1

    THE STUDY INDICATES THAT DURING A PHONE CALL WITH THE GENERAL PRACTITIONER, THE MOTHER OF THE PATIENT INDICATED THAT THE PATIENT HAD INCREASING SHORTNESS OF BREATH AND SUBSEQUENTLY EXPIRED TWO DAYS LATER WHEN BEING TRANSPORTED TO THE HOSPITAL. THE PATIENT IS A MALE WITH BMI 21.5 KG/M2 WAS ENROLLED IN THE STUDY IN 2007, WITH 1-VESSEL DISEASE EXTENT (NO STAGING). MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDAEMIA, CURRENT SMOKER, TYPE 1 DIABETES MELLITUS TREATMENT WITH INSULIN, PERIPHERAL VASCULAR DISEASE (PVD), MODERATE TO SEVERE RENAL DISEASE WITH NO KNOWN ALLERGIES OR HYPERSENSITIVITIES AND NO IMMUNOCOMPROMISE DEFICIENCY. PRE-PROCEDURE TREATMENT MEDICATIONS WERE ASPIRIN 160MG (>30 DAYS), ACE INHIBITORS/ANGIOTENSIN RECEPTOR BLOCKERS AND BETA BLOCKERS. THE INDEX PROCEDURE WAS COMPLETED IN THE SAME DAY WITH AN INDICATION OF STABLE ANGINA PECTORIS. HEART RATE AT THE BEGINNING OF THE PROCEDURE WAS 78 BEATS/MIN AND BLOOD PRESSURE WAS 144/67 MMHG. MEDICATIONS AT TIME OF INDEX PROCEDURE WERE CLOPIDOGREL 600MG (IN CATH LAB), ASPIRIN (NO BOLUS GIVEN), AND UNFRACTIONATED HEPARIN. A GPIIB/IIIA INHIBITOR WAS NOT ADMINISTERED.

    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 UNDEFINED

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death AND A PILOT 50 GUIDEWIRE| 6FRENCH GUIDING CATHETER| 2.0X 20MM DILATATION CATHETER