BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 12450935 · Received September 9, 2021

    Report

    Report Number
    2024168-2021-08051
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 22, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT WAS REPORTED XIENCE PRIME STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING REMOVAL AND FORCE WAS ULTIMATELY USED TO REMOVE THE DEVICE. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTION FOR USE STATES: APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENT. IN THIS CASE, IT DOES NOT APPEAR THE INSTRUCTIONS FOR USE DEVIATION CAUSED AND/OR CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO REMOVE; HOWEVER, FACTORS THAT MAY CONTRIBUTE DIFFICULTY TO REMOVE INCLUDE, BUT ARE NOT LIMITED TO, INCORRECT DESIGN, INCOMPLETE DEFLATION, AND INTERACTION WITH ANATOMY. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSE AND MILDLY CALCIFIED DE NOVO LESION IN THE LEFT CIRCUMFLEX ARTERY. A 2.75X18MM XIENCE PRIME STENT WAS DEPLOYED AT NOMINAL PRESSURE; HOWEVER, POST-STENTING DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM (SDS) AFTER DEFLATION WAS NOTED. IN AN ATTEMPT TO REMOVE THE SDS THE SDS WAS INFLATED TO 4 ATMOSPHERES, DEFLATED FOR 4-6 SECONDS, AND THE PUSH PULL METHOD WAS USED. THE BALLOON WAS FULLY DEFLATED BUT WITH GREAT DIFFICULTY AND FORCE THE SDS WAS ABLE TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348312 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1030241

    Patients

    Seq Age Sex Outcome Treatment
    1