BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8267502 · Received January 22, 2019

    Report

    Report Number
    2024168-2019-00481
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    December 27, 2018
    Report Date
    April 1, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODES: 2645 LABELED NA. INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER WAS UPDATED FROM 8032341 TO UNK; SERIAL NUMBER UPDATED FROM (B)(4) TO UNK. CORRECTION: MANUFACTURING SITE UPDATED FROM (B)(4) TO (B)(4). CORRECTION: PATIENT CODE 2199 WAS REMOVED AND REPLACED WITH CODE 2645. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE STENT OF THE 2.25 X 23 MM XIENCE SIERRA WAS FOUND TO BE FLARED AND THE STENT LOOSE AND MOVING ON THE BALLOON DURING PREPARATION. ANOTHER 2.25 X 23 MM XIENCE SIERRA WAS OPENED AND ADVANCED; HOWEVER, IT FAILED TO CROSS DUE TO THE CALCIFIED LESION. WHEN REMOVED FROM THE PATIENT, THE STENT STRUTS WERE NOTED TO BE FLARED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE RETURNED FOR INVESTIGATION. 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 AN UNKNOWN LESION. WHEN A GUIDE WIRE WAS INSERTED THROUGH THE TIP OF THE 2.25 X 23 MM XIENCE SIERRA STENT DELIVERY SYSTEM, IT WAS NOTED THAT THE STENT WAS FLARED AND THAT THE STENT WAS LOOSE AND MOVING ON THE BALLOON. A NEW 2.25 X 23 MM XIENCE SIERRA WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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
    61917 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8032341

    Patients

    Seq Age Sex Outcome Treatment
    1