BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1061183 · Received June 13, 2008

    Report

    Report Number
    9616099-2008-01512
    Event Type
    Death
    Date Received
    June 13, 2008
    Date of Event
    February 26, 2008
    Report Date
    May 21, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 EVALUATION. ADDITIONAL INFO IS NOT AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED, AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, UPON ADMISSION TO THE STUDY, THIS PATIENT PRESENTED WITH RESTENOSIS OF A PREVIOUSLY PLACED CYPHER STENT IN THE LEFT CIRCUMFLEX. LESIONS TREATED DURING THE INDEX PROCEDURE INCLUDED THE MID RIGHT CORONARY ARTERY (RAC), THE MID CIRCUMFLEX, THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE PROXIMAL LEFT CIRCUMFLEX. FIVE MOS POST PROCEDURE, THE PT UNDERWENT CABG. ANGIOGRAPHY PRIOR TO THE CABG REVEALED 50% FOCAL IN-STENT STENOSIS IN THE MID RCA WITH NO PERI-STENT PATTERN. THERE WAS NO ANEURYSM AT THE SITE OF THE PROCEDURE. TIMI III FLOW WAS RECORDED. THERE WAS 0% RESTENOSIS IN THE MID CIRCUMFLEX WITH NO PERI-STENT RESTENOSIS PATTERN AND NO ANEURYSM AT THE SITE OF THE PROCEDURE. TIMI III FLOW WAS RECORDED. THERE WAS ALSO 0% RESTENOSIS IN THE LAD WITH NO PERI-STENT PATTERN AND NO ANEURYSM AT THE SITE OF THE PROCEDURE. TIMI III FLOW WAS RECORDED. IN THE PROXIMAL CIRCUMFLEX, THERE WAS 30% FOCAL IN-STENT RESTENOSIS WITH NO PERI-STENT RESTENOSIS PATTERN AND NO ANEURYSM AT THE SITE OF THE PROCEDURE. TIMI III FLOW WAS RECORDED. DOUBLE CABG WAS PERFORMED ON THE RCA AND THE LAD WITHOUT REVASCULARIZATION OF THE TARGET LESIONS. IMMEDIATELY POST PROCEDURE, THE PT HAD AURICULAR FIBRILLATION TREATED BY MEDICATION, SUB-OCCLUSIVE SYNDROME WITH SPONTANEOUS FAVORABLE EVOLUTION. POST CHIRURGICAL EVOLUTION WAS FAVORABLE. ONE WEEK LATER, THE PT EXPERIENCED SUDDEN CARDIAC DEATH. THERE WAS NO EVIDENCE OF STENT THROMBOSIS OR MYOCARDIAL INFARCTION. AN AUTOPSY WAS NOT PERFORMED. THE EVENT WAS CLASSIFIED AS UNRELATED TO THE STUDY DEVICES AND INDEX PROCEDURE. THIS PT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 3-VESSEL DISEASE WAS FOUND. FOUR LESIONS WERE TREATED DURING THE INDEX PROCEDURE. THE PRIMARY INDICATION FOR INTERVENTION WAS UNSTABLE ANGINA PECTORIS (TROPONIN NEGATIVE OR UNK). PRE-PROCEDURE CK AND TROPONIN WERE WITHIN NORMAL LIMITS. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS AND ACE INHIBITORS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND UNFRACTIONATED HEPARIN. PCI WAS PERFORMED ON AN 85% FOCAL IN-STENT RESTENOTIC LESION (AFTER PHYTIS STENT) IN THE MID RIGHT CORONARY ARTERY (RCA) OF 12 MM IN LENGTH IN A 3.0 MM VESSEL DIAMETER. THE (B) CONCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.0 X 10 MM BALLOON AT 12 ATMOSPHERES (ATMS) BEFORE A 3.0 X 13 MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 12 ATMS WITH SATISFACTORY RESULTS. POST-DILATATION WAS CONDUCTED WITH A 3.0 X 13 MM BALLOON AT 12 ATMS BECAUSE THE STENT WAS NOT FULLY EXPANDED. THE RESIDUAL DIAMETER STENOSIS WAS 0%. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. PCI WAS PERFORMED NEXT ON A 70% FOCAL IN-STENT RESTENOTIC LESION (2.5 X 33 MM CYPHER STENT) IN THE MID CIRCUMFLEX OF 16 MM IN LENGTH IN A 2.25 MM VESSEL DIAMETER. THE (B1) CONCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. A 2.25 X 18 MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 12 ATMS BY DIRECT STENTING WITH SATISFACTORY RESULTS. POST-DILATATION WAS NOT CONDUCTED. THE RESIDUAL DIAMETER STENOSIS WAS NOT DOCUMENTED. PRE AND POST-PROCEDURE THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOWS WERE NOT DOCUMENTED. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. PCI WAS PERFORMED ON A 75% DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) OF 10 MM IN LENGTH IN A 2.5 MM VESSEL DIAMETER AT A BIFURCATION REQUIRING DOUBLE GUIDEWIRE. THE (B1) CONCENTRIC LESION WAS CHARACTERIZED AS OSTIAL, A SMOOTH CONTOUR, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. A 3.0 X 13 MM CYPHER SELECT PLUS STENT WAS DEPLOYED BY DIRECT STENTING AT 12 ATMS BY V-STENTING/KISSING STENTING WITH SATISFACTORY RESULTS. THE RESIDUAL DIAMETER STENOSIS WAS 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. PCI WAS PERFORMED ON A 40% DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX OF 16 MM IN LENGTH IN A 3.0 MM VESSEL DIAMETER AT A BIFURCATION REQUIRING DOUBLE GUIDEWIRE. THE (B1) CONCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, OSTIAL, LITTLE TO NO CALCIFICATION AND THROMBUS ABSENT. A 3.0 X 18 MM CYPHER SELECT PLUS STENT WAS DEPLOYED BY DIRECT STENTING AT 12 ATMS BY V-STENTING/KISSING STENTING WITH SATISFACTORY RESULTS. THE RESIDUAL DIAMETER STENOSIS WAS 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. POST-PROCEDURE CK AND TROPONIN WERE WITHIN NORMAL LIMITS. THERE WERE NO PROCEDURAL COMPLICATIONS AND THE PT WAS DISCHARGED TWO DAYS LATER. POST PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 1 MONTH, STATINS AND ACE INHIBITORS. DURING THE 1-MONTH FOLLOW-UP, THE PT WAS ASYMPTOMATIC FOR ANGINAL SYMPTOMS. POST PROCEDURE MEDICATIONS REMAINED THE SAME. NO NEW ADVERSE EVENTS OR SURGERIES WERE REPORTED.

    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 13263239

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R MEDICATIONS: PRE AND POST-PROCEDURE MEDICATIONS| INCLUDED: ASPIRIN| ACE INHIBITORS. INTRA-PROCEDURE MEDICATIONS| INCLUDED ASPIRIN| HEPARIN| DEVICES: 2 X 10MM BALLOON