BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2241461 · Received September 9, 2011

    Report

    Report Number
    3003742446-2011-00410
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 17, 2010
    Report Date
    August 17, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT # 3003742446-2011-00410, # 3003742446-2011-00411, AND # 3003742446-2011-00412.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE PATIENT/INITIAL REPORTER THROUGH THE (B)(4) DEPARTMENT INDICATED THAT THE PATIENT HAD A TOTAL OF (B)(4) CYPHER STENTS IMPLANTED DURING THE INDEX PROCEDURE. THE STENTS WERE REPORTED TO HAVE BEEN IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING (LAD) TARGET LESIONS. APPROXIMATELY THIRTY NINE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED PAINS IN HIS THROAT. CORONARY ANGIOGRAPHY/RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) WAS PERFORMED AND THE PREVIOUSLY IMPLANTED STENTS WERE REPORTED TO BE CLOGGED/RESTENOSED. THE STENTS WERE RE-OPENED AND AN ADDITIONAL ABBOTT COBALT CHROMIUM STENT WAS IMPLANTED. THE PATIENT'S MEDICAL HISTORY INCLUDES: CORONARY ARTERY DISEASE (CAD), HYPERTENSION (HTN), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), DIABETES, CANCER OF THE BLADDER, BRONCHITIS, AND SMOKING, MULTIPLE ATTEMPTS TO RETRIEVE DETAILED INFORMATION REGARDING THE PRODUCTS AND THE EVENTS REPORTED WERE UNSUCCESSFUL. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS 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 (SPECIFICALLY DIABETES AND SMOKING) 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. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 3003742446-2011-00410, # 3003742446-2011-00411, AND # 3003742446-2011-00412.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE PATIENT/INITIAL REPORTER THROUGH THE MEDICAL AFFAIRS DEPARTMENT INDICATED THAT THE PATIENT HAD A TOTAL OF THREE (3) CYPHER STENTS IMPLANTED DURING THE INDEX PROCEDURE. THE STENTS WERE REPORTED TO HAVE BEEN IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING (LAD) TARGET LESIONS. APPROXIMATELY THIRTY NINE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED PAINS IN HIS THROAT. CORONARY ANGIOGRAPHY/RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) WAS PERFORMED AND THE PREVIOUSLY IMPLANTED STENTS WERE REPORTED TO BE CLOGGED/RESTENOSED. THE STENTS WERE RE-OPENED AND AN ADDITIONAL ABBOTT COBALT CHROMIUM STENT WAS IMPLANTED. APPROXIMATELY EIGHT MONTHS AFTER THE RE-PCI, THE PATIENT WAS REPORTED TO BE SCHEDULED FOR SURGICAL REMOVAL OF A KIDNEY AND URETER DUE TO CANCER REQUIRING A TEN DAY ADMISSION. THE DIAGNOSIS OF CANCER AND SUBSEQUENT SURGERY WAS CAPTURED AS A NON-COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 A0406116

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R