BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION

    MDR report key: 10391986 · Received August 11, 2020

    Report

    Report Number
    2024168-2020-06680
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 26, 2020
    Report Date
    August 11, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NAD1: BRAND NAME CHANGED FROM XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO RX XIENCE XPEDITION 48 D4: CATALOG NUMBER CHANGED FROM 1070275-33 TO 1070300-48 D4: UDI CHANGED FROM (B)(4) TO (B)(4).

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE ELECTRONIC INSTRUCTION FOR USE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS XIENCE XPEDITION, CE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS. PRE-DILATATION WAS PERFORMED WITH A 1.5X12MM AND 2.0X12MM MINITREK BALLOONS AT 8 ATMOSPHERES (ATM). A 3X48MM XIENCE XPEDITION STENT WAS DEPLOYED AT 10 ATM. DURING REMOVAL OF THE DELIVERY SYSTEM, A DISSECTION WAS NOTED AT THE DISTAL END. DISSECTION WAS TREATED WITH A 2.75X33MM XIENCE XPEDITION. RESULTS WERE VERY GOOD WITH TIMI III FLOW AND NO RESIDUAL STENOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855873 XIENCE XPEDITION DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 9061941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention