BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3900766 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04188
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    September 18, 2012
    Report Date
    June 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT IS GENERALLY A KNOWN EFFECT ASSOCIATED WITH THE USE OF THE DEVICE AND THE PROCEDURES IN WHICH IT IS UTILIZED. IN THE ABSENCE OF ANY REPORTED DEVICE MALFUNCTION, A POTENTIAL RELATIONSHIP BETWEEN THE REPORTED PATIENT EFFECT AND A DEVICE ISSUE IS UNLIKELY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, NEW INFORMATION WAS RECEIVED AS FOLLOWS: THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2010. ON (B)(6) 2012, THE PATIENT HAD UNDERGONE INTRAVASCULAR ULTRASOUND REVEALING A TOTALLY OCCLUDED RIGHT CORONARY ARTERY, NOT THE LEFT ANTERIOR DESCENDING ARTERY AS PREVIOUSLY REPORTED, FOR WHICH ELECTIVE CORONARY ARTERY BYPASS WAS PERFORMED. THERE WAS NO RESTENOSIS OF THE PREVIOUSLY DEPLOYED STENT CONFIRMED. THE PATIENTS CURRENT CONDITION IS SATISFACTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A 2.75X18 MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. BASED ON RESULTS FROM ANGIOGRAPHY ON (B)(6) 2012, THE PATIENT UNDERWENT CORONARY ARTERY BYPASS OF THE TARGET VESSEL ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377813 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9061541

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R| S