BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2080898 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03283
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RESTENOSIS IS A KNOWN ADVERSE EVENT LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    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 PROMUS STENT IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE 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 DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2009, A 2.5 X 28 PROMUS AND 2.75 X 18 PROMUS WERE IMPLANTED. DURING THE PROCEDURE, THE PATIENT COMPLAINED OF PAIN AND EXPERIENCED A MYOCARDIAL INFARCTION. ADDITIONALLY, IT WAS NOTED THAT A PERFORATION OCCURRED, WHICH WAS TREATED WITH 3 ADDITIONAL STENTS. POST-PROCEDURE, THE PATIENT COMPLAINED OF TINGLING AND PAIN IN HER CHEST WHEN PERFORMING BRISK ACTIVITIES. ON (B)(6) 2011, A NUCLEAR STRESS TEST REVEALED THAT ONE STENT WAS BLOCKED. 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 9031242

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other STENT: PROMUS 2.75 X 18