BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1870228 · Received October 11, 2010

    Report

    Report Number
    2024168-2010-02136
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    June 16, 2010
    Report Date
    September 16, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL AND DEVICE INFORMATION. THE 2.5 X 23 MM XIENCE V (1009539-23, 0030441) AND 3.5 X 18 MM XIENCE V (1009542-18, 9122142) ARE EACH BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, 3 XIENCE V STENTS WERE DEPLOYED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH WAS MILDLY TORTUOUS, MILDLY CALCIFIED. THE LESION WAS PREDILATED. THE 2.5 X 23MM XIENCE V STENT WAS IMPLANTED IN THE MOST DISTAL PART, THEN THE 3.0 X 28MM XIENCE V STENT IN THE MIDDLE AND THEN THE 3.5 X 18MM XIENCE V IN THE PROXIMAL PART OF THE LESION. ALL THREE STENTS WERE IMPLANTED OVERLAPPING THE NEXT. POST-DILATATION OF THE IMPLANTED STENTS WAS PERFORMED AT 12-14 ATMOSPHERES USING THE SDS BALLOON. ON (B)(6) 2010, THE PATIENT RETURNED FOR ANGIOGRAPHY TO EXAMINE THE REMAINING LESION IN THE DIAGONAL AND TO FOLLOW-UP ON THE PREVIOUSLY TREATED LESION IN THE LAD. THE LAD WAS CONFIRMED TO BE OCCLUDED AND THROMBOSIS WAS OBSERVED, STARTING FROM THE AREA PROXIMAL TO THE 3.5 X 18MM STENT AND THROUGH TO THE 2.5 X 23 MM STENT IMPLANTED IN THE MOST DISTAL PART. THROMBOSIS WAS OBSERVED INSIDE ALL OF THE IMPLANTED XIENCE V STENTS. ASPIRATION WAS PERFORMED USING AN ASPIRATION CATHETER. THEN, BALLOONING WAS PERFORMED USING NON ABBOTT BALLOON CATHETERS. THE PHYSICIAN ASSUMES THE THROMBOSIS FORMATION OCCURRED AS A RESULT OF THE STENT DEPLOYMENT, AS THE THROMBOSIS WAS CONFIRMED TO BE PRESENT FOR THE ENTIRE LENGTH OF THE LESION COVERED BY THE IMPLANTED STENTS, STARTING FROM EXACTLY WHERE THE PROXIMAL EDGE OF THE MOST PROXIMALLY IMPLANTED XIENCE V. 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 0030841

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R GUIDE WIRE: FIELDER| STENT: 2.5 X 23 MM XIENCE V (1009539-23, 0030441)| 3.5 X 18 MM XIENCE V (1009542-18, 9122142)| DIL CATH: TAZUNA (X3)| LACROSSE| X-TREME| CONQUESTOPRO| GUIDE CATH: AXESS 7F JL3.5SH