BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 24006010 · Received January 8, 2026

    Report

    Report Number
    2024168-2026-00160
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    August 29, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357176
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 OF SPECIFIC ISSUE. THE REPORTED PATIENT EFFECTS OF OCCLUSION AND PAIN ARE LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS 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 REPORTED TREATMENT APPEARS TO BE RELATED TO 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. THE OTHER DEVICE REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. CORRECTIONS: D4 ¿ MODEL #, CATALOG #: UPDATED FROM UNK ESPRIT BTK TO 1203375-38. D4 ¿ LOT #: UPDATED FROM UNKNOWN TO 5050761. D4 - PRIMARY UDI NUMBER: UPDATED FROM UNKNOWN TO (B)(4).

    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. THE REPORTED PATIENT EFFECTS OF OCCLUSION AND PAIN ARE LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE 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 REPORTED TREATMENT APPEARS TO BE RELATED TO 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. THE OTHER DEVICE REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, TWO 3.75X38 MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE LEFT LOWER LIMB: ONE IN THE TIBIO-PERONEAL TRUNK TO THE POSTERIOR TIBIAL ARTERY AND THE SECOND IN THE PERONEAL ARTERY. TWO NON-TARGET LESIONS ON THE LEFT LOWER LIMB WERE ALSO TREATED AT THE INDEX STUDY PROCEDURE. TWO DAYS POST PROCEDURE, ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WITH WORSENING FOOT PAIN IN THE INDEX LIMB. IT WAS DETERMINED THAT THE LIMB PAIN IS LIKELY SECONDARY TO ACUTE REPERFUSION FROM ARTERIALIZATION OF THE POSTERIOR TIBIAL VEIN. THE PATIENT WAS TREATED WITH A HEPARIN INTRAVENOUS DRIP. THE CONDITION RESOLVED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE CLINIC FOR A FOLLOW-UP VISIT. THE PATIENT WAS ADMITTED FOR SCANS AND OBSERVATIONS. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN FOUND AN OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY AND NO FLOW IN THE CALF ARTERIES. THE FOOT WAS NOT SALVAGEABLE. AMPUTATION WAS PERFORMED ABOVE THE LEFT KNEE ON (B)(6) 2025. THE PATIENT WAS DISCHARGED FROM THE AMPUTATION ADMISSION ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS FOUND UNRESPONSIVE AT HIS ASSISTED LIVING FACILITY. THE PATIENT'S PULSE WAS ABSENT WITH NO RISE/FALL OF THE PATIENT'S CHEST. THE PATIENT WAS PRONOUNCED DEAD WITH THE PRIMARY SYMPTOM LISTED AS CARDIAC ARREST. IN THE OPINION OF THE PHYSICIAN, THE INDEX STUDY DEVICES ARE NOT RELATED TO THE CARDIAC ARREST/ PATIENT DEMISE. THERE WERE NO ONGOING COMPLICATIONS FROM THE AMPUTATION THAT CONTRIBUTED TO THE PATIENT¿S DEMISE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61741 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203375-38 5050761 08717648357176

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Disability| H| R 3.75 X 38 MM ESPRIT SCAFFOLD.