BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3790560 · Received May 5, 2014

    Report

    Report Number
    2024168-2014-02813
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 15, 2012
    Report Date
    April 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE ESTIMATED AS (B)(6) 2010. 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 EFFECTS OF ANGINA AND RESTENOSIS AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF A CORONARY STENTS IN NATIVE CORONARY ARTERIES. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN ON (B)(6) 2012. IT WAS NOTED THAT THE PREVIOUSLY IMPLANTED PROMUS STENT WAS FOUND TO BE 90% RE-STENOSED IN THE MID RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND A NON-ABBOTT STENT WAS IMPLANTED FOR TREATMENT. DURING POST-DILATATION OF THE NON-ABBOTT STENT, A PLAQUE SHIFT OCCURRED IN THE FIRST DIAGONAL. A NON-ABBOTT EXTRA SUPPORT WIRE WAS ADVANCED AND BALLOON DILATATION WAS PERFORMED USING A 2.5 MM BALLOON. RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269271 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0062441

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R