BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1901734 · Received November 17, 2010

    Report

    Report Number
    3003742446-2010-00413
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    December 1, 2006
    Report Date
    November 30, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IMPLANTED SOMETIME IN 2004.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A CYPHER PATIENT CALLED MEDICAL AFFAIRS REQUESTING MRI SAFETY INFORMATION DUE TO A TORN ROTATOR CUFF AND ADDITIONALLY REPORTED ADVERSE EVENTS. TWO YEARS POST CYPHER STENT PLACEMENT IN AN UNKNOWN ARTERY FOR AN UNSPECIFIED REASON HER SYMPTOMS REOCCURRED AND ANGIOGRAM REVEALED THE PREVIOUSLY TREATED LESION WAS OCCLUDED AGAIN. THE PATIENT HAD TO HAVE OPEN HEART SURGERY. THE PATIENT HAS HAD NO FURTHER SYMPTOMS. IT WAS REPORTED THAT SHE HAD BEEN COMPLIANT WITH HER ASPIRIN AND PLAVIX. IT WAS REPORTED THAT THE PATIENT DID NOT WANT TO BE CONTACTED FURTHER AND DID NOT WANT TO PROVIDE ANY ADDITIONAL INFORMATION. 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 41203657 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CORONARY ARTERY REOCCLUSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENT, VESSEL AND PROCEDURAL FACTORS ALONG WITH PROGRESSION OF EXISTING CORONARY ARTERY DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED INSTENT RESTENOSIS; HOWEVER, BASED ON THE LACK OF CLINICAL AND PROCEDURAL INFORMATION, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE CONTRIBUTING FACTORS. BASED ON THE DEVICE HISTORY REVIEW THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    A CYPHER PATIENT CALLED REQUESTING MRI SAFETY INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. IN 2004, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN ARTERY FOR AN UNSPECIFIED REASON. HER SYMPTOMS CAME BACK IN 2006 AND ANGIOGRAM REVEALED THAT HER PREVIOUSLY TREATED LESION WAS OCCLUDED AGAIN. PATIENT HAD TO HAVE OPEN HEART SURGERY IN (B)(6) 2006. SINCE HER IMPLANT IN 2004, PATIENT HAD BEEN COMPLIANT WITH HER ASPIRIN AND PLAVIX MEDICATION. SINCE 2006, THE PATIENT HAS NOT HAD ANY OTHER SYMPTOMS. PATIENT ALSO REPORTED THAT IN 2010, AN X-RAY WAS TAKEN FOR A POSSIBLE TORN ROTARY CUFF AND WOULD NEED AN MRI FOR FURTHER DIAGNOSIS. NO TREATMENT WAS REPORTED FOR THIS ONGOING EVENT. NO FURTHER INFORMATION WAS AVAILABLE AS THE PATIENT REFUSED. PATIENT DID NOT WANT TO BE CONTACTED FURTHER AND DID NOT WANT TO GIVE ANY MORE INFORMATION.

    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) 41203657

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ASPIRIN, PLAVIX