BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953204 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00140
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DILATATION CATHETER: 2.5 X 8 MM QUANTUM APEX, 2.75 X 12 MM MAVERICK; GUIDE WIRE: CHOICE PT FLOPPY, BMW; STENT: 2.75 X 15MM PROMUS, 2.5 X 8 MM PROMUS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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 AND THE TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INDEX PROCEDURE ON (B)(6) 2010, A 3.0 X 18 MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.75 X 15 MM PROMUS STENT WAS ALSO DEPLOYED IN THE MID LAD; DISTAL TO THE STENT A SLIGHT SPASM WAS NOTED, WHICH WAS TREATED WITH A TOTAL OF 400 MCG OF NITROGLYCERIN AND IMPROVEMENT WAS NOTED. A 2.5 X 8 MM PROMUS STENT WAS DEPLOYED IN THE OSTIUM OF THE FIRST DIAGONAL ARTERY. THE PROCEDURE WAS CONSIDERED SUCCESSFUL AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2010, ANGIOGRAPHY WAS PERFORMED AND A 90% RESTENOSIS WAS FOUND IN THE DISTAL END OF THE STENT IN THE PROXIMAL LAD. THE OTHER TWO PROMUS STENTS WERE PATENT. THE RESTENOSIS WAS TREATED WITH A 3.0 X 8 MM PROMUS STENT. POST DILATATION WAS PERFORMED WITH AN NON-ABBOTT BALLOON CATHETER. PROCEDURE WAS CONSIDERED SUCCESSFUL. PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY, LONG TERM. NO ADDITIONAL INFORMATIONS WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R