BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3103076 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02907
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 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 2.25X38 PROMUS STENT REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS 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) 2012, A DE NOVO TARGET LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25X24 NON-ABBOTT STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ON 18 DEC 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. ON (B)(6) 2013, 108 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. CORONARY ANGIOGRAPHY REVEALED A LAD 100% MID OCCLUSION; 80-90% FAIRLY EXTENSIVE IN-STENT RESTENOSIS IN THE DISTAL LIMA TO LAD (ANASTOMOSIS). THE LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.25X26 NON-ABBOTT STENT. ADDITIONALLY ON THE SAME DAY, 90% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED 2.25X38 PROMUS STENT IN THE MID RAMUS ARTERY AND A 2.25X12 PROMUS STENT IN THE DISTAL SEGMENT OF THE RAMUS ARTERY WERE TREATED WITH BALLOON ANGIOPLASTY. THE PROMUS STENTS WERE IMPLANTED IN THE RAMUS ARTERY ON (B)(6) 2012. THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202864 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R STENT: 2.25X38 PROMUS