BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 9825441 · Received March 12, 2020

    Report

    Report Number
    2024168-2020-02349
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    November 15, 2019
    Report Date
    September 17, 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

    NAG4 - THE LOT NUMBER WAS CHANGED FROM 9071641 TO 7081641 G4 - THE EXPIRATION DATE WAS CHANGED FROM 7/22/2022 TO 8/21/2020. H4 - THE MANUFACTURING DATE WAS CHANGED FROM 7/23/2019 TO 8/22/2017.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 XIENCE PRIME, XIENCE PRIME SMALL VESSEL (SV), AND XIENCE PRIME LONG LENGTH (LL), EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE 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 MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DE NOVO RIGHT CORONARY ARTERY THAT WAS 99% STENOSED. PRE-DILATATION WAS DONE WITH AN UNSPECIFIED BALLOON. A 3.0X23MM XIENCE PRIME STENT WAS DEPLOYED AND A DISTAL EDGE DISSECTION OCCURRED. A NEW XIENCE PRIME STENT WAS DEPLOYED TO COVER THE DISSECTION AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288036 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 7081641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention