BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA

    MDR report key: 9245169 · Received October 28, 2019

    Report

    Report Number
    2024168-2019-12971
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 3, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227448
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DEFLATION ISSUE WAS UNABLE TO BE CONFIRMED. 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. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DEFLATION ISSUES AS THE ISSUE WAS NOT CONFIRMED DURING RETURN DEVICE ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.LOT NUMBER WAS CHANGED FROM 8042541 TO 804254A.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.50X28MM XIENCE SIERRA STENT WAS INFLATED TWO TIMES AT NOMINAL PRESSURE AND DEPLOYED, THE DEVICE WAS HELD FOR 30 SECONDS ON NEGATIVE IN ATTEMPTS TO DEFLATE THE BALLOON. HOWEVER, IT TOOK A LONGER TIME TO DEFLATE THE BALLOON THAN USUAL. AFTER THE BALLOON DEFLATION WAS CONFIRMED, THE DELIVERY SYSTEM WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040449 XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 804254A 08717648227448

    Patients

    Seq Age Sex Outcome Treatment
    1 EVEREST INFLATION DEVICE