BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2220627 · Received August 23, 2011

    Report

    Report Number
    3003742446-2011-00388
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND UPDATED. THE SON OF A CYPHER STENT PATIENT CALLED REQUESTING MEDICAL INFORMATION AND ADDITIONALLY REPORTED AN ADVERSE EVENT. THE (B)(6) FEMALE PATIENT HAD A CYPHER STENT PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY FOR AN UNSPECIFIED REASON. APPROXIMATELY THREE YEARS LATER, THE PATIENT EXPERIENCED "CHEST PAIN" "NAUSEA" AND " SWEATING." TREATMENT REPORTED WAS INPATIENT HOSPITALIZATION WHERE IT WAS DETERMINED THAT THE STENT WAS "COMPLETELY BLOCKED." THE SON REPORTED THAT THE CARDIOLOGIST WAS "GOING TO ATTEMPT TO TREAT THE BLOCKAGE WITH MEDICATION." HE STATED THAT NO ADDITIONAL STENT WAS IMPLANTED. NO FURTHER INFORMATION WAS AVAILABLE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (ADVANCED AGE AND PROGRESSION OF DISEASE), THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE SON OF A CYPHER STENT PATIENT CALLED REQUESTING MEDICAL INFORMATION AND ADDITIONALLY REPORTED AN ADVERSE EVENT. ON (B)(6) 2008, MOTHER HAD A CYPHER STENT PLACED IN LAD FOR AN UNSPECIFIED REASON. BEGINNING (B)(6) 2011, MOTHER EXPERIENCED "CHEST PAIN" "NAUSEA" AND "SWEATING." TREATMENT REPORTED WAS INPATIENT HOSPITALIZATION BEGINNING (B)(6) 2011 WHERE IT WAS DETERMINED THAT THE STENT WAS "COMPLETELY BLOCKED." EVENT AND HOSPITALIZATION ARE ONGOING. SON REPORTED THAT THE CARDIOLOGIST WAS "GOING TO ATTEMPT TO TREAT THE BLOCKAGE WITH MEDICATION." NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    SPOKE WITH THE REPORTER AND HE CONFIRMED THAT HIS MOTHER HAD A CYPHER STENT IMPLANTED ON (B)(6) 2008. HE STATED THAT ON (B)(6) 2011 THE CYPHER STENT WAS "BLOCKED" AND WAS BEING TREATED WITH LOTS OF MEDICATION. HE STATED THAT NO ADDITIONAL STENT WAS IMPLANTED. HE DID NOT KNOW THE TYPE OF MEDICATION USED TO TREAT THE CYPHER STENT. HE STATED HIS MOTHER WAS DOING OKAY. HE REFUSED TO GIVE PERMISSION TO CONTACT THE TREATING PHYSICIAN. HE STATED HE DID NOT HAVE ANY ADDITIONAL 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) NA 13333454

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R