BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1822455 · Received August 26, 2010

    Report

    Report Number
    2024168-2010-01765
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT DISLODGEMENT. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: MEDICAL/SURGICAL INTERVENTION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY (RCA) INTERVENTION OF AN ANGULATED VESSEL THAT WAS HIGHLY CALCIFIED, PRIMARY STENTING WITH A 3.0X12 PROMUS WAS ATTEMPTED WITHOUT PREDILATATION; HOWEVER, THE PROMUS DID NOT CROSS. THERE WAS DIFFICULTY ADVANCING TO THE LESION DUE TO RESISTANCE. THE DEVICE WAS TAKEN OUT AND A 3.0X8 PROMUS WAS ADVANCED. EXCESSIVE FORCE WAS APPLIED IN AN ATTEMPT TO GET THE DEVICE TO CROSS THE LESION AND THE STENT MIGRATED OFF THE BALLOON, ALTHOUGH THE STENT DID NOT MOVE IN THE BODY ONCE IT DISLODGED. MULTIPLE TECHNIQUES WERE ATTEMPTED TO RETRIEVE THE STENT OFF THE GUIDE WIRE INCLUDING AN ATTEMPT TO PULL THE DEVICE BACK INTO THE GUIDE CATHETER AS WELL AS USING A SECOND GUIDE WIRE AND ANOTHER BALLOON; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL AND THE PT WAS SENT FOR SURGERY IN ORDER TO REMOVE THE STENT. 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R GUIDE CATH: XB RCA GUIDE CATHETER (CORTIS)| GUIDE WIRE: ATW MARKER WIRE (CORTIS)