BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1836404 · Received September 13, 2010

    Report

    Report Number
    2024168-2010-01897
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 19, 2010
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE STENT; 3.0 X 23 MM XIENCE V (PART 1009541-23, LOT 0021741) IS BEING FILED UNDER SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 50 MM LONG LESION IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). AFTER DEPLOYING THE XIENCE 3.0 X 23 IN THE PROXIMAL RCA, THE XIENCE 3.0 X 18 WAS DELIVERED TOWARD THE MID RCA. HOWEVER, DURING ADVANCEMENT, THE STENT BECAME STUCK WITH THE DISTAL PART OF THE DEPLOYED STENT. THE STENT DELIVERY SYSTEM (SDS) COULD NOT BE WITHDRAWN AND WHEN STRONG FORCE WAS APPLIED, ONLY THE SDS WAS WITHDRAWN FROM THE PT'S ANATOMY AS THE STENT HAD DISLODGED FROM THE BALLOON. ADDITIONALLY, THE TWO STENTS WHICH WERE STUCK TOGETHER WERE PULLED OUT OF THE CORONARY, INTO THE AORTA, AS THE GUIDE WIRE ALSO DISENGAGED FROM THE CORONARY WHEN THE CATHETER WAS PULLED STRONGLY. THE TWO STENTS WERE FOUND IN THE COMMON ILIAC ARTERY IN CT SCAN. TWO NON-ABBOTT STENTS WERE DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO ATTEMPT TO REMOVE OR DEPLOY THE DISLODGED STENTS AS THE PT'S CONDITION WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9122241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other STENT: 3.0 X 23 MM XIENCE V| (PART 1009541-23, LOT 0021741)