BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132904 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04331
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE PRODUCT AND ITS PACKAGING WERE NOT RETURNED; THEREFORE, THE EXPIRATION DATE ON THE SPECIFIC PRODUCT LABELS COULD NOT BE CONFIRMED. HOWEVER, A REVIEW OF THE LABELS ATTACHED TO THE LOT HISTORY RECORD (LHR) FOR THIS LOT WAS CONDUCTED AND ALL LABELS INDICATED AN EXPIRATION DATE (USE BY DATE) OF 04-MAY-2011, WHICH IS 24 MONTHS FROM THE DATE OF MANUFACTURE, AS SPECIFIED IN THE PRODUCT SPECIFICATION AT THE TIME THIS LOT WAS MANUFACTURED. THIS CONFIRMS THAT THE PRODUCT WAS LABELED CORRECTLY, AND BASED ON THE REPORTED INFORMATION THE PRODUCT WAS USED 20 DAYS PAST THE LABELED EXPIRATION DATE. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR THE STERILITY, EFFICACY AND PERFORMANCE OF THE DEVICE. IT SHOULD BE NOTED THAT THE PROMUS INSTRUCTIONS FOR USE INDICATES TO NOTE THE USE BY (EXPIRATION) DATE ON THE PRODUCT LABEL. IN THIS CASE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALTHOUGH THE EXACT CAUSE OF WHY THE PRODUCT WAS USED AFTER EXPIRATION COULD NOT BE DETERMINED FROM THE REPORTED INFORMATION, IT APPEARS THAT USE ERROR LIKELY CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR USE AFTER EXPIRATION DATE FROM THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A STENTING PROCEDURE WITH ONE PROMUS 2.5 X 28 STENT ON (B)(6) 2011. IT WAS NOTED AFTER THE IMPLANTATION THAT THE DEVICE EXPIRED ON (B)(6) 2011. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9041061

    Patients

    Seq Age Sex Outcome Treatment
    1