BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPAMYCIN CLINICAL 3.0 X 18 MM

    MDR report key: 1021284 · Received March 25, 2008

    Report

    Report Number
    9610978-2008-00080
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    February 9, 2007
    Report Date
    March 7, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALE IN THE CLINICAL TRIAL EXPERIENCED RESTENOSIS OF A CYPHER STENT. MEDICAL HISTORY INCLUDED HYPERTENSION. DURING THE INDEX PROCEDURE, ONE 3.0/18MM CLINICAL RAPAMYCIN STENT WAS IMPLANTED IN THE MID-LAD AT 10 ATM. VESSEL/LESION CHARACTERISTICS WERE DESCRIBED AS 90% STENOSED WITH 15MM LESION LENGTH AND TIMI I FLOW. TIMI III FLOW WAS RESTORED AND THE PROCEDURE WAS CONSIDERED SUCCESSFUL. APPROXIMATELY 5 YEARS LATER, THE PATIENT BEGAN EXPERIENCING ANGINAL SYMPTOMS. ATRIAL FIBRILLATION AND REDUCED EJECTION FRACTION (25%) LEADING TO HEART FAILURE WERE ALSO DIAGNOSED. ANGIOGRAPHY PERFORMED A FEW MONTHS LATER DEMONSTRATED 99% STENOSIS INVOLVING THE LEFT MAIN THROUGH THE PROXIMAL PORTION MID-LAD (PREVIOUSLY STENTED SEGMENT). TREATMENT INCLUDED "SUCCESSFUL" IMPLANTATION OF 2 CYPHER SELECT STENTS. TWO MONTHS LATER, HE REMAINED ASYMPTOMATIC. EIGHT MONTHS LATER, HE WAS EXPERIENCING SOME DYSPNEA BUT WAS CONSIDERED "STABLE". THE STENT COULD NOT BE RETURNED FOR EVALUATION; IT REMAINED IMPLANTED. 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 POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE INFORMATION AVAILABLE SUGGEST THAT PROGRESSION OF EXISTING CORONARY DISEASE MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THIS IS AN INITIAL AND FINAL REPORT. THE EMAIL RECEIVED FROM THE STUDY INDICATES THAT APPROXIMATELY 5 YEARS POST INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION TO THE TARGET LESION (MID LEFT ANTERIOR DESCENDING). THE RESTENOSIS WAS TREATED WITH TWO CYPHER SELECT STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPAMYCIN CLINICAL 3.0 X 18 MM NONE NIQ CORDIS EUROPA, N.V. NA S0601971

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R