BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT BTK RX IDE

    MDR report key: 19704579 · Received July 9, 2024

    Report

    Report Number
    2024168-2024-08072
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    May 16, 2024
    Report Date
    February 27, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648234149
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE REPORTED PATIENT EFFECTS OF PAIN AND STENOSIS ARE LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING BIORESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    B5 - DESCRIBE EVENT OR PROBLEM: UPDATED AS ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    PATIENT ID: (B)(6). IT WAS REPORTED THE PATIENT HAS A HISTORY OF RENAL DISEASE AND PERIPHERAL ARTERY DISEASE. ON (B)(6) 2021, THE PATIENT UNDERWENT STENTING WITH TWO ESPRIT BTK SCAFFOLDS (3.0X38MM AND 3.5X38MM) IN THE TIBIOPERONEAL ARTERY. ON (B)(6) 2024 THE PATIENT EXPERIENCED PAIN IN THE LEFT LOWER LIMB. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED FOR DISCOMFORT AND PAIN IN THE LOWER LIMB. PHYSICAL EXAMINATION SHOWED NON-SWELLING, NON-REDNESS EXTREMITIES, WITH TRACE PULSATION OF LEFT DORSALIS PEDIS. LAB DATA SHOWED IMPAIRED KIDNEY FUNCTIONAL PROFILE AS BASELINE. PER THE CARDIOLOGIST NO CRITICAL LIMB ISCHEMIA WAS FOUND, AND KEEPING THE PATIENT ON REGULAR MEDICATIONS WAS FEASIBLE. DUE TO PERIPHERAL ARTERIAL OCCLUSIVE DISEASE, THE PATIENT WAS ADMITTED TO FOR FURTHER EVALUATION. IT IS POSSIBLE THE PAIN IS RELATED TO THE ESPRIT SCAFFOLDS. ASPIRIN 100 MG AND PLETAAL 100 MG WAS GIVEN ON (B)(6) 2024. THE PATIENT IS IN STABLE CONDITION. ON (B)(6) 2024, A LOWER LIMB DUPLEX ULTRASOUND WAS PERFORMED SHOWING MODERATE STENOSIS OF THE LEFT COMMON FEMORAL ARTERY, FEMORAL ARTERY AND POPLITEAL ARTERY. RESTENOSIS WAS NOT TREATED. PAIN MEDICATION WAS GIVEN AND THE PATIENT WAS DISCHARGED ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2024 THE PATIENT HAD A WORSENING OF HIS EXISTING CONDITION. THERE WAS 90% STENOSIS AT THE DISTAL SCAFFOLD EDGE IN THE LEFT TIBIOPERONEAL TRUNK. THIS WAS TREATED WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251229 ESPRIT BTK RX IDE STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. 1202350-38 00521P5001 08717648234149

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H SCAFFOLD: 3.0X38 MM ESPRIT BTK RX IDE.| SCAFFOLD: ESPRIT BTK 3.0X38MM.