BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 21100882 · Received January 8, 2025

    Report

    Report Number
    2024168-2025-00293
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357251
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY SCAFFOLD PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D4 - LOT # UPDATED FROM UNKNOWN TO 4071061.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY/DORSALIS PEDIS. PRE-DILATATION WAS PERFORMED WITH A 2.5MM BALLOON AND BROUGHT TO NOMINAL; HOWEVER, THE PHYSICIAN STATED THE VESSEL SEEMED A LITTLE SMALL BUT IT WAS A PROCEDURE THAT NEEDED TO BE PERFORMED. A 2.50X38MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE TARGET LESION AND POST DILATATION PERFORMED WITH THE DELIVERY SYSTEM. PER THE PHYSICIAN, THE STENT MAY HAVE BEEN OVERSIZED FOR THE VESSEL. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2024, A CHECK OF THE SCAFFOLD WAS PERFORMED AND THE SCAFFOLD WAS NOTED TO HAVE BEEN OCCLUDED. A LASER WAS USED THROUGH THE LESION AND MULTIPLE BALLOONS WERE PERFORMED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105141 ESPRIT¿ STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. 1203250-38 4071061 08717648357251

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H