BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211525 · Received October 22, 2008

    Report

    Report Number
    2024168-2008-01001
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 29, 2008
    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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - THE XIENCE IFU STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER)." IT WAS REPORTED THAT ALL OF THE TARGET LESIONS WERE NOT PRE-DILATED. IT SHOULD BE NOTED THAT THE IFU STATES, "PRE-DILATE THE LESION WITH A PTCA CATHETER." IN THIS CASE, IT IS POSSIBLE THAT THE DIRECT STENTING MAY HAVE CONTRIBUTED TO THE DISSECTION. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR INJURY. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRAIL THAT THE INDEX PROCEDURE WAS PERFORMED IN 2008. TWO 3.0 X 15 MM XIENCE V STENTS WERE IMPLANTED IN THE DISTAL FIRST OBTUSE MARGINAL. A 2.5 X 15 MM XIENCE V STENT WAS IMPLANTED IN THE DISTAL RCA. AFTER IMPLANT OF A 3.0 X 8 MM XIENCE V STENT IN THE MID RCA, A DISSECTION WAS NOTED PROXIMAL TO THE STENT IMPLANT. A 2.75 X 23 MM XIENCE V STENT WAS USED TO TREAT THE DISSECTION. ALL STENTS WERE DIRECT STENTED AND NO PRE-DILATATION WAS PERFORMED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    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 7112661

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention XIENCE V STENTS 3.0 X 15 MM (2)| STENTS: 2.5 X 15MM XIENCE V