BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1201528 · Received October 17, 2008

    Report

    Report Number
    9616099-2008-02470
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    June 8, 2008
    Report Date
    September 21, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE US. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT APPROXIMATELY NINE MONTHS POST CYPHER IMPLANT, THE PATIENT UNDERWENT TARGET VESSEL REVASCULARIZATION DUE TO STENOSIS IDENTIFIED IN THE PREVIOUSLY STENTED SEGMENT. THE PATIENT PRESENTED WITH TWO-VESSEL DISEASE; THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE PROXIMAL LAD ARTERY (PLAD). THE LESION WAS 12 MM LONG WITH A 2.5 REFERENCE VESSEL DIAMETER. THE LESION PRESENTED 80% STENOSIS AND TIMI III FLOW. THE DE NOVO LESION WAS ECCENTRIC WITH IRREGULAR CONTOUR PRESENTING HEAVY CALCIFICATION AND WAS CLASSIFIED AS TYPE B2. THE LESION WAS TREATED WITH A 2.5X13 MM CYPHER STENT, WHICH WAS DEPLOYED AT 16 ATMOSPHERES. THEN TO FULLY EXPAND THE STENT, POST-DILATION WAS CONDUCTED TO 20 ATMS. POST PROCEDURE, THE LESION PRESENTED 0% STENOSIS AND TIMI III FLOW. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. DURING THE SIX-MONTH FOLLOW UP, THE PATIENT PRESENTED WITH ANGINA PECTORIS; HOWEVER, THERE WAS NO TREATMENT PERFORMED. APPROXIMATELY, NINE MONTHS POST PROCEDURE, A CORONARY ANGIOGRAPHY WAS PERFORMED; THE TARGET LESION PRESENTED TIMI III FLOW, NO STENT RESTENOSIS, NO PERI-STENT RESTENOSIS AND 0% DIAMETER STENOSIS. HOWEVER, THE SAME SEGMENT TREATED DURING THE INDEX PROCEDURE PRESENTED WITH 70% STENOSIS; THEREFORE, THE LESION WAS TREATED WITH A RESOLUTE 2.5X12 STENT. POST STENTING, THE LESION PRESENTED 0% POST PROCEDURE. THE EVENT WAS RESOLVED WITHOUT SEQUEL. DURING THE ONE-YEAR FOLLOW UP, THE PATIENT REMAINED 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 NA 13242740

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R CLOPIDOGREL| ASPIRIN| UNFRACTIONATED HEPARIN| STATINS| BETA BLOCKERS| 7FR GUIDING CATHETER| ACE INHIBITORS| ANGIOTENSIN RECEPTOR BLOCKERS| 2.5 X 10MM POST DILATION BALLOON