BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153064 · Received September 8, 2008

    Report

    Report Number
    9616099-2008-02181
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 10, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. A MALE PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY EXPERIENCED RESTENOSIS APPROXIMATELY SEVEN MONTHS POST IMPLANTATION OF AN UNKNOWN CYPHER STENT. THE PATIENT UNDERWENT A PCI TO TREAT A LESION IN THE POSTERIOR DESCENDING BRACH OF THE RCA. THE LESION WAS DESCRIBED AS 99% ISR OF AN UNKNOWN CYPHER STENT PREVIOUSLY IMPLANTED. THERE WAS NO INFORMATION AVAILABLE ABOUT THIS INITIAL PROCEDURE. THE LOT NUMBER AND EXACT DATE OF IMPLANTATION WERE NOT AVAILABLE. THE LESION WAS TREATED WITH THE IMPLANTATION OF A 2.5 X 23 MM CYPHER. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR ANALYSIS. THE LOT NUMBER OF THE RESTENOSED CYPHER STENT WAS INQUIRED, BUT UNFORTUNATELY THE HOSPITAL WAS NOT ABLE TO RETRIEVE IT, THEREFORE IT IS NOT POSSIBLE TO PROVIDE A DHR. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT. THIS IS ONE OF TWO PRODUCT USED FOR THE SAME PATIENT. PLEASE REFERENCED MFR. REPORT #9616099-2008-02182.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT APPROXIMATELY SEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS FOUND TO HAVE A 99% RESTENOSIS OF A PREVIOUSLY IMPLANTED UNKNOWN CYPHER STENT. THE STENT WAS IMPLANTED IN THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) TARGET LESION IN 2008. THE RESTENOSIS WAS TREATED BY IMPLANTATION OF AN ADDITIONAL CYPHER 2.5 X 23 MM STENT. NO PROCEDURAL DETAILS OF THE INDEX PROCEDURE FOR THIS DEVICE WERE AVAILABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| R