BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1162673 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02260
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    June 4, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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 INFORMATION RECEIVED INDICATED THAT THE PATIENT UNDERWENT STENTING OF A LESION IN THE RIGHT CORONARY ARTERY (RCA). APPROXIMATELY SIX MONTHS POST STENTING PROCEDURE, STENT THROMBOSIS AND RESTENOSIS WERE IDENTIFIED. THE PATIENT WAS ENROLLED IN THE STUDY AND THE LESION WAS TREATED WITH A 3X33MM CYPHER; ELEVEN MONTHS POST - STENTING PROCEDURE, STENT RESTENOSIS WAS CONFIRMED. THE MAIN INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE MRCA. THE LESION WAS 27 MM LONG WITH A 3.0 REFERENCE VESSEL DIAMETER, TIMI FLOW WAS III AND THE LESION PRESENTED 95% DIAMETER STENOSIS. AS INDICATED BY THE PATIENT'S MEDICAL HISTORY, THE TARGET VESSEL HAD BEEN PREVIOUSLY TREATED WITH A CYPHER STENT; THE VESSEL PRESENTED THROMBOSIS WHICH WAS CONFIRMED VIA ANGIOGRAPHY. THEREFORE, THE TARGET LESION WAS DESCRIBED AS RESTENOTIC LESION WITH PROLIFERATIVE IN STENT RESTENOSIS. THE LESION WAS FURTHER DESCRIBED AS ECCENTRIC WITH SMOOTH CONTOUR. THERE WAS NO CALCIFICATION OR THROMBUS AND WAS CLASSIFIED AS TYPE B1. THE LESION WAS SUCCESSFULLY PRE-DILATED TO 20 ATMS, THEN WAS TREATED WITH A 3.00X33MM CYPHER STENT, WHICH WAS DEPLOYED AT 21 ATMS. RESULTS WERE SATISFACTORY. POST PROCEDURE THE LESION PRESENTED TIMI III FLOW AND 0% STENOSIS. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION OR ADVERSE EVENTS TO THE PATIENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY, THERE WAS NO INJURY OR ADVERSE EVENTS REPORTED AT THE TIME OF DISCHARGE. APPROXIMATELY ELEVEN MONTHS POST-STENTING PROCEDURE, AN ANGIOGRAPHY WAS CONDUCTED, REVEALED FOCAL IN STENT RESTENOSIS < 10MM LONG AND 90% STENOSIS; THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION. ANGIOGRAPHY CONFIRMED THE PRESENCE OF A SIGNIFICANT LESION JUDGED TO REQUIRE REVASCULARIZATION. THE LESION WAS TREATED WITH A 3X23MM XIENCE V STENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBER: 9616099-2008-02259.

    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 13209228

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R UNFRACTIONED HEPARIN| CLOPIDOGREL| ACE INHIBITORS| DIABETES ORAL ANTIDIABETICS AND INSULIN| DEVICES - 6FR GUIDING CATHETER| 3.5 X 15MM BALLOON CATHETER| STATINS| BETA BLOCKERS| PATIENT'S MEDICATION ASPIRIN