BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1974842 · Received January 31, 2011

    Report

    Report Number
    2024168-2011-00565
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    September 28, 2010
    Report Date
    January 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). ALTHOUGH 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.

    Description of Event or Problem · 1

    REPORTEDLY THE SUBJECT WAS RANDOMIZED INTO THE (B)(4) STUDY ON (B)(6) 2009. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH 95% STENOSIS, A LENGTH OF 12 MM, AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION WAS TREATED WITH THE PLACEMENT OF A 2.50 X 18 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2009, THE PATIENT EXPERIENCED NON-CARDIAC CHEST PAIN. ON (B)(6) 2010, THE SUBJECT WAS HOSPITALIZED WITH ANGINA PECTORIS, ONSET DATE (B)(6) 2010. ON (B)(6) 2010, 434 DAYS POST INDEX PROCEDURE, THE CORONARY ANGIOGRAPHY REVEALED 70% STENOSIS OF THE MID LAD. THE MID LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND A DRUG-ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2010. PER INVESTIGATOR, THE RELATIONSHIP TO THE INDEX PROCEDURE IS POSSIBLE. NO ADDITIONAL EVENT OR PATIENT 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 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R