BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 22905438 · Received August 27, 2025

    Report

    Report Number
    2024168-2025-09141
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    January 1, 2024
    Report Date
    August 27, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE REPORTED PATIENT EFFECT OF THROMBOSIS 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. B3, D6: DATES ESTIMATED. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ATTACHMENT: ARTICLE TITLED, ¿EMERGING HYBRID INTRACORONARY IMAGING TECHNOLOGIES AND THEIR APPLICATIONS IN CLINICAL PRACTICE AND RESEARCH¿.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A RESEARCH ARTICLE REGARDING INTRAVASCULAR ULTRASOUND, OPTICAL COHERENCE TOMOGRAPHY AND THE EVOLUTION IN THE FIELD OF HYBRID INTRACORONARY IMAGING IT WAS NOTED THAT RESEARCH SUPPORTING THE ROLE OF STANDALONE INTRACORONARY IMAGING IN THE CLINICAL PRACTICE WITH VARIOUS TRIALS INCLUDING THE XIENCE PRIME STENT OBSERVED THE RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACES) WHICH INCLUDE (CARDIAC DEATH, STENT THROMBOSIS, TARGET LESION REVASCULARIZATION AND TARGET VESSEL REVASCULARIZATION) RATE WAS SIGNIFICANTLY LOWER IN THE IVUS-GUIDED REVASCULARIZATION GROUP COMPARED TO ANGIOGRAPHY. POSTMORTEM HISTOLOGY STUDIES HAVE DOCUMENTED THAT HYBRID IMAGING CATHETERS CAN ENABLE MORE ACCURATE CHARACTERIZATION OF PLAQUE MORPHOLOGY THAN STANDALONE IMAGING. THE USE OF MULTIMODALITY IMAGING MAY IMPROVE OUTCOMES FOLLOWING INTERVENTIONAL TREATMENT IN CHALLENGING CLINICAL SCENARIOS. TO DETERMINE THE ROLE OF HYBRID INTRACORONARY IMAGING IN GUIDING REVASCULARIZATION, CARDIOVASCULAR RISK STRATIFICATION AND PLAQUE DETECTION A LARGER SCALE OF STUDIES ARE NEEDED. SPECIFIC PATIENT INFORMATION REMAINS UNKNOWN. ADDITIONAL INFORMATION CAN BE FOUND IN THE ATTACHED ARTICLE "EMERGING HYBRID INTRACORONARY IMAGING TECHNOLOGIES AND THEIR APPLICATIONS IN CLINICAL PRACTICE AND RESEARCH". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499003 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H