BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2590714 · Received May 29, 2012

    Report

    Report Number
    2024168-2012-03384
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    March 22, 2012
    Report Date
    May 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND OCCLUSION ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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

    IT WAS REPORTED THAT DURING THE INDEX PROCEDURE ON (B)(6) 2010, DUE TO RECOIL OF THE NON-ABBOTT STUDY STENT, A 3.0X23 MM PROMUS STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY; HOWEVER, POST DEPLOYMENT OF THE PROMUS STENT, THE 1ST DIAGONAL WAS OBSERVED TO BE JAILED. BALLOON ANGIOPLASTY WAS PERFORMED USING A NON-ABBOTT BALLOON TO REOPEN THE ARTERY. THE PATIENT WAS DISCHARGED. ON (B)(6) 2012, 523 DAYS POST INDEX PROCEDURE, THE PATIENT WAS REHOSPITALIZED WITH CHEST PAIN. ANGIOGRAPHY REVEALED THAT THE PREVIOUSLY JAILED 1ST DIAGONAL HAD A 90% LESION. ON (B)(6) 2012, THE PATIENT UNDERWENT BALLOON ANGIOPLASTY WITH A NON-ABBOTT BALLOON TO REOPEN THE ARTERY, REDUCING THE LESION TO 0%. THE PATIENT WAS DISCHARGED. 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 0050762

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R