BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT BTK RX IDE

    MDR report key: 20339313 · Received September 30, 2024

    Report

    Report Number
    2024168-2024-11508
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 15, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648233883
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE REPORTED PATIENT EFFECT OF STENOSIS IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY SCAFFOLD PROCEDURES.

    Description of Event or Problem · 0

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022 EIGHT ESPRIT BTK SCAFFOLDS (FOUR 2.5X28, TWO 3.0X38, ONE 3.0X28, ONE 3.5X28) WERE IMPLANTED IN THE LEFT MID ANTERIOR TIBIAL ARTERY (ATA) IN AN INVESTIGATIONAL DEVICE, CLINICAL STUDY PATIENT WHO HAS AN EXTENSIVE MEDICAL HISTORY AND MULTIPLE COMORBIDITIES. ON (B)(6) 2024, THE TWO-YEAR POST PROCEDURE CLINICAL FOLLOW UP WAS PERFORMED. TWO RESTENOSIS LESIONS WERE FOUND ON ULTRASOUND, WITH NO PATIENT SYMPTOMS AND NO DEVICE MALFUNCTION IDENTIFIED. IN THE PHYSICIAN'S OPINION, THE RESTENOSIS WAS NOT RELATED TO THE SCAFFOLD. RESTENOSIS IS NOT UNUSUAL IN VASCULAR DISEASE PATHOLOGY. ANKLE BRACHIAL PRESSURE INDEX VALUE WAS 1.2. THERE WERE NO WOUNDS ON THIS LIMB. THE PATIENT WAS ALREADY ON DUAL ANTIPLATELET THERAPY. NO ADDITIONAL TREATMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006521 ESPRIT BTK RX IDE STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. 1202250-28 20122P5 08717648233883

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other