BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1913301 · Received December 3, 2010

    Report

    Report Number
    3003742446-2010-00434
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    January 1, 2005
    Report Date
    November 10, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY A PATIENT TO CORDIS MEDICAL AFFAIRS, APPROXIMATELY TWO YEARS AFTER A 3.0 X 18MM CYPHER RX WAS IMPLANTED IN AN UNKNOWN VESSEL FOR AN UNKNOWN INDICATION, HE HAD TWO ADDITIONAL UNSPECIFIED STENTS IMPLANTED IN UNKNOWN VESSELS DUE TO AN UNKNOWN EVENT. AFTER PROVIDING MRI SAFETY INFORMATION THE PATIENT REFUSED TO PROVIDE ADDITIONAL INFORMATION. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE VERY LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE A RELATIONSHIP OR ANY CONTRIBUTING FACTORS BETWEEN THE REPORTED EVENTS AND THE IMPLANTED DEVICE. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMAITON WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY A PATIENT TO CORDIS MEDICAL AFFAIRS, APPROXIMATELY TWO YEARS AFTER A 3.0 X 18MM CYPHER RX WAS IMPLANTED IN AN UNKNOWN VESSEL FOR AN UNKNOWN INDICATION, HE HAD TWO ADDITIONAL UNSPECIFIED STENTS IMPLANTED IN UNKNOWN VESSELS DUE TO AN UNKNOWN EVENT. AFTER MEDICAL AFFAIRS PROVIDED REQUESTED MRI SAFETY INFORMATION, THE PATIENT REFUSED TO PROVIDE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT SYSTEM DIAGNOSTIC TESTS RESULTED IN HIGH LEAD IMPEDANCE DURING AN OFFICE VISIT. THE REPORTER STATED THAT THERE IS NO KNOWN TRAUMA THAT MAY HAVE CAUSED THE HIGH LEAD IMPEDANCE. THE PT'S GENERATION HAS BEEN TURNED OFF AND X-RAYS WERE TAKEN. X-RAYS WERE RECEIVED AND EVALUATED BY THE MFR. REVIEW OF X-RAYS INDICATED THE GENERATOR WAS PLACED IN THE LEFT CHEST IN A NORMAL ORIENTATION. THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED. THE LEAD APPEARED TO BE INTACT AT THE CONNECTOR PIN AND SOME LEAD WAS PRESENT BEHIND THE GENERATOR. THE FILTER FEED-THRU WIRES APPEARED TO BE INTACT AT THE CONNECTOR PIN. THE ALIGNMENT OF THE POSITIVE AND NEGATIVE ELECTRODES APPEARED TO BE NORMAL. HOWEVER, A SUSPECT LEAD DISCONTINUITY WAS SEEN ON THE POSITIVE ELECTRODE IN THE NECK AREA. THE PT WILL MOST LIKELY BE REFERRED FOR REVISION SURGERY. HOWEVER, NO SURGERY HAS BEEN PLANNED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention