BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2028792 · Received March 24, 2011

    Report

    Report Number
    2024168-2011-01977
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 28, 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). IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE STENT MAY HAVE BEEN A PROMUS ELEMENT BECAUSE HE REPORTEDLY BELIEVED THAT THE RADIOPACITY WAS GREATER THAN WHAT IS EXPECTED OF A PROMUS STENT. AN ATTEMPT WAS MADE TO GET ADDITIONAL INFORMATION ON THE TYPE OF CONTRAST USED AND CONTRAST DILUTION RATIO UTILIZED DURING THE PROCEDURE, BUT THIS INFORMATION WAS NOT AVAILABLE. IN THIS CASE, BOTH AN ABBOTT CLINICAL SPECIALIST AND AN ABBOTT CLINICAL RESEARCH AND DEVELOPMENT SPECIALIST STATED THAT BASED ON THE CINE PROVIDED, THE TYPE OF STENT DEPLOYED COULD NOT BE CONFIRMED SINCE THE STENT PATTERN WAS NOT DISCERNABLE IN THE IMAGES. ADDITIONALLY, THE ANALYSIS NOTED THAT THE RADIOPACITY OF THE STENT DID NOT APPEAR UNUSUAL IN THE CINE IMAGES. THE REPORTED GREATER RADIOPACITY OF THE STENT AND THE TYPE OF THE STENT DEPLOYED COULD NOT BE CONFIRMED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. FACTORS WHICH MAY AFFECT RADIOPACITY VISUALIZATION DURING THE PROCEDURE INCLUDE, BUT ARE NOT LIMITED TO, STENT DESIGN, PATIENT ANATOMY/SIZE, PROCEDURAL CONTRAST, AND/OR VISUALIZATION EQUIPMENT. A MISLABELED PRODUCT COULD RESULT FROM A MANUFACTURING DISCREPANCY OR FROM A MIX-UP AT THE DISTRIBUTOR OR ACCOUNT. TO HELP ENSURE THAT THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, STENT DELIVERY SYSTEMS ARE SUBJECTED TO VISUAL INSPECTION AND PRODUCT LABELING IS SUBJECT TO A VISUAL INSPECTION AND VERIFICATION DURING MANUFACTURING OF THE LOT AT ABBOTT VASCULAR. THE PRODUCT AND PACKAGING WERE NOT RETURNED, AND MAY HAVE AIDED IN THE INVESTIGATION. THE LOT HISTORY RECORD REVIEW DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR MISLABELING FOR THIS LOT. BOSTON SCIENTIFIC (BSC) ALSO PERFORMED AN INTERNAL INVESTIGATION AND DETERMINED THAT THERE IS NO INDICATION THAT A PRODUCT MIX UP BETWEEN PROMUS AND PROMUS ELEMENT COULD HAVE OCCURRED. IN THIS CASE, THERE IS NO INDICATION THAT THE REPORTED MIX-UP/MISLABELING OCCURRED DURING THE MANUFACTURE AND PACKAGING OF THE PRODUCT AT ABBOTT VASCULAR. ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED POTENTIAL MISLABELING/MIX-UP, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    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 STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.5 X 18 PROMUS STENT SYSTEM WAS REMOVED FROM THE PACKAGING CONFIRMED TO BE LABELED AS A 3.5 X 18 PROMUS. THE STENT WAS SUCCESSFULLY IMPLANTED IN THE MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY. AFTER DEPLOYMENT OF THE STENT, THE PHYSICIAN FELT THAT THE STENT MAY HAVE BEEN A PROMUS ELEMENT BECAUSE THE RADIOPACITY WAS GREATER THAN WHAT IS EXPECTED OF A PROMUS STENT. THE SHAPE OF THE STENT APPEARED TO BE NORMAL. THE PHYSICIAN EXPRESSED CONCERN OF A POSSIBLE LABELING ISSUE. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 0083141

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR