BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153067 · Received September 8, 2008

    Report

    Report Number
    9616099-2008-02185
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    April 21, 2008
    Report Date
    August 12, 2008
    Manufacturer
    CORDIS DE MEXICO, S.A. DE C.V.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13276166 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE REGISTRY INDICATED THAT APPROXIMATELY FIVE MONTHS POST STENTING PROCEDURE, FOCAL STENT RESTENOSIS WAS IDENTIFIED IN ONE STENT. THE MAIN INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE LESION WAS LOCATED AT A BIFURCATION IN THE PROXIMAL CIRCUMFLEX CORONARY (PCIRC) AND THE FIRST OBTUSE MARGINAL BRANCH (1ST OM). THE LESION WAS REPORTED TO BE 6MM WITH A 2.5 REFERENCE VESSEL DIAMETER AND 60% DIAMETER STENOSIS. THE LESION WAS DE-NOVO, SMOOTH CONTOUR, COCENTRIC WITH LITTLE CALCIFICATION. LESION TYPE B2. THE ORIGINAL INTENTION OF THE PROCEDURE WAS BALLOON ANGIOPLASTY ONLY AND SINCE THE LESION WAS AT A BIFURCATION A DOUBLE WIRE TECHNIQUE WAS USED. AFTER CANNULATING THE LEFT MAIN ARTERY, TWO GUIDEWIRES WERE POSITIONED; ONE IN THE PCIRC AND ONE IN THE RAMUS INTERMEDIUS CORONARY ARTERY. ONE AVION PLUS BALLOON CATHETER 2.5 X 10MM WAS POSITIONED IN THE OSTIUM OF THE CIRCUMFLEX ARTERY. FOUR INFLATIONS WERE PERFORMED UP TO A MAXIMUM PRESSURE OF 6 ATMOSPHERES (ATM); ANOTHER 2.00 X 10MM AVION PLUS BALLOON CATHETER WAS POSITIONED IN THE RAMUS INTERMEDIUS CORONARY ARTERY. ONE INFLATION WAS PERFORMED UP TO A MAXIMAL PRESSURE OF 6 ATM. HOWEVER A SEVERE SPIRAL OCCLUSIVE DISSECTION (TYPE F) IN THE PCIRC AND MID CIRC OCCURRED. AS A RESULT, TO TREAT THE DISSECTION, TWO CYPHER STENTS, A 2.5X23MM AND A 2.5X13MM, WERE IMPLANTED. THE FIRST STENT IMPLANTED WAS THE 2.5X23MM WHICH WAS DEPLOYED IN THE PROXIMAL CIRCUMFLEX TO 10 ATM; THE SECOND STENT, 2.5X13MM, WAS DEPLOYED OVERLAPPING THE DISTAL END OF THE FIRST STENT AND WAS DEPLOYED TO 12 ATMS. POST PROCEDURE DIAMETER STENOSIS WAS 30%. RESULTS WERE SATISFACTORY AND THERE WAS NO POST-DILATION CONDUCTED 2.5X23MM. THERE WERE NO OTHER COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY ONE-MONTH POST STENTING PROCEDURE, THE PATIENT PRESENTED WITH ANGINA PECTORIS; A CORONARY ANGIOGRAM WAS PERFORMED AND NO TREATMENT WAS CONDUCTED. HOWEVER, A NUCLEAR SCAN WAS PLANNED. APPROXIMATELY FIVE MONTHS POST STENTING PROCEDURE, THE PATIENT PRESENTED WITH ANGINA PECTORIS - STABLE ANGINA CLASS 3 WHICH LED TO HOSPITALIZATION. ANGIOGRAPHY WAS CONDUCTED AND THE 2.5X23MM STENT PRESENTED FOCAL IN STENT RESTENOSIS (LESS THAN 10MM) AND PROXIMAL PERI-STENT RESTENOSIS WITH 99% STENOSIS. THE RESTENOSIS WAS MORE 5MM AWAY FROM SECOND STENT IMPLANTED 2.5X13MM. THEREFORE, TARGET LESION REVASCULARIZATION WITH BALLOON DILATATION ONLY, WAS CONDUCTED. FOUR DAYS POST ADMISSION, THE PATIENT WAS DISCHARGED. DURING THE SIX MONTH FOLLOW-UP, THE PATIENT WAS ASYMPTOMATIC.

    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, S.A. DE C.V. NA 13276166

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 2.0X10 BALLOON CATHETER| UNFRACTIONED HEPARIN| 6F GUIDE CATHETER| 2.5X10 BALLOON CATHETER| ACE INHIBITORS| CLOPIDOGREL| MEDICATIONS INCLUDED ASPIRINE