BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1142752 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00730
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: DISLODGED STENT REMAINS IN THE CORONARY. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE STENT BECAME DISLODGED DURING ADVANCEMENT TO THE LESION AND IT WAS LOST IN THE PATIENT'S CORONARY. THREE DIFFERENT GUIDING CATHETERS WERE USED AS IT WAS DIFFICULT TO OBTAIN A GOOD SEAT. PRE-DILATION WAS DONE WITH A VOYAGER. THERE WAS AN ATTEMPT TO ADVANCE THE STENT INTO THE RIGHT CORONARY ARTERY (RCA), BUT RESISTANCE WAS ENCOUNTERED DUE TO CALCIFICATION. THE GUIDING CATHETER BECAME UNSEATED AND VESSEL ACCESS WAS LOST WITH THE GUIDE WIRE. NO RETRIEVAL ATEMPT OF THE STENT WAS MADE. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION 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 8052161

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability DIL CATH: VOYAGER