BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1830873 · Received September 8, 2010

    Report

    Report Number
    2024168-2010-01871
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 15, 2010
    Report Date
    August 15, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DISSECTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MFR, DESIGN, OR LABELING. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DISSECTION REQUIRING INTERVENTION. TIME OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY THE PHYSICIAN WAS STENTING THE OSTIAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A 2.75 MM X 28 MM XIENCE V. THERE WAS A DISSECTION OF THE MID LAD AT THE DISTAL EDGE OF THE XIENCE V DURING IMPLANTATION. REPORTEDLY, THE LESION WAS CALCIFIED. THE PHYSICIAN USED ANOTHER 2.75 MM X 12 MM XIENCE V AT THE MID LAD TO TREAT THE DISTAL EDGE DISSECTION. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 0012841

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention WHISPER ES GUIDE WIRE| JL4 GUIDE CATHETER