BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

    MDR report key: 8663410 · Received June 3, 2019

    Report

    Report Number
    2024168-2019-04303
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 3, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY (WALL APPOSITION); HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE XIENCE PROA IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE 2.75X33MM XIENCE PROA STENT MENTIONED WAS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 3.5X12MM XIENCE PROA STENT WAS PLACED PROXIMAL TO THE PREVIOUSLY IMPLANTED 2.75X33MM XIENCE PROA STENT. POST IMPLANTATION, THE 3.5/12MM XIENCE PROA STENT EXPANSION WAS AT 92%. THE MAXIMUM SIZED BALLOON AT HIGH PRESSURE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455765 XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8111261

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 2.75X33MM XIENCE PROA STENT