BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1784639 · Received July 30, 2010

    Report

    Report Number
    2024168-2010-01545
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 6, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 2.5 X 28 MM PROMUS (PART 1009539-28B, LOT 0042943). INDICATED IS BEING FILED UNDER A SEPARATE MFR#. (B)(4).

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT DISLODGEMENT. ADVERSE EVENT: MEDICAL INTERVENTION TO EMBED DISLODGED STENT. ONSET OF ADVERSE EVENT: DURING PROCEDURE. IT WAS REPORTED THAT A 2.5 X 28 MM PROMUS STENT AND A NON-ABBOTT STENT WERE IMPLANTED OVERLAPPING IN THE LEFT CIRCUMFLEX (CX) IN (B)(6) 2009; HOWEVER, THE PATIENT WAS NON-COMPLIANT AND HAD QUIT TAKING ALL PRESCRIBED ANTI-PLATELET THERAPY (ASPIRIN AND PLAVIX, DATE UNKNOWN). THE PATIENT PRESENTED WITH CHEST PAIN AND AN MI ON (B)(6)2010. THE LEFT CX WAS TOTALLY OCCLUDED WITH THROMBUS. THE LESION WAS PREDILATED WITH MULTIPLE BALLOONS. AN ATTEMPT WAS MADE TO ADVANCE THE 2.5 X 15 MM PROMUS STENT DELIVERY SYSTEM (SDS) TO THE LESION WITH FORCE AS THE LESION WAS EXTREMELY TORTUOUS IN THE LEFT MAIN THAT CONTAINED A NON-ABBOTT STENT. THE PATIENT BECAME AGITATED AND PULLED OUT THE GUIDE CATHETER, GUIDE WIRE AND ALL DEVICES THAT WERE IN AT THE TIME. THE DEVICES WERE EXAMINED AND IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON OF THE SDS. VIA ANGIO, IT WAS CONFIRMED THAT THE STENT HAD DISLODGED IN THE LEFT MAIN AT THE SITE OF THE NON-ABBOTT STENT. THE PROMUS STENT WAS CRUSHED AGAINST THE VESSEL WALL WITH AN UNKNOWN BARE METAL STENT. THE TREATMENT OF THE THROMBOSIS WAS COMPLETED WITH THE PREDILATION. NO FURTHER PATIENT COMPLICATIONS OCCURRED. THE PATIENT HAS BEEN DISCHARGED AND INSTRUCTED TO RESUME ANTI-PLATELET THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0020261

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention| S (PART 1009539-28B, LOT 0042943)| STENT: 2.5 X 28 MM PROMUS