BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT¿

    MDR report key: 23771553 · Received December 10, 2025

    Report

    Report Number
    2024168-2025-11947
    Event Type
    Death
    Date Received
    December 10, 2025
    Date of Event
    November 3, 2025
    Report Date
    January 19, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. CORRECTIONS: B3 - DATE OF EVENT: UPDATED FROM 11/12/2025 TO 11/3/2025. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED, AS ADDITIONAL INFORMATION WAS PROVIDED. H6 - HEALTH EFFECT - CLINICAL CODE: CODE 4441 WAS REMOVED AND CODE 4582 WAS ADDED. H6 - HEALTH EFFECT - IMPACT CODE: CODES 1802 AND 4607 WERE REMOVED AND CODE 4657 WAS ADDED. H11 - ADDITIONAL MFR NARRATIVE: UPDATED BASED ON ADDITIONAL INFORMATION.

    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 DEATH IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY SCAFFOLDING PROCEDURES. 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

    Description of Event or Problem · 0

    (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025 TWO 3.5X38 MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE RIGHT PERONEAL ARTERY. ON (B)(6) 2025 THE PATIENT HAD AN OVERNIGHT HOSPITAL STAY FOLLOWING A REVASCULARIZATION PROCEDURE IN THE ANTERIOR TIBIAL ARTERY. THE PATIENT WAS OBSERVED TO BE SHORT OF BREATH AND WEAK AFTER GOING TO THE BATHROOM. HE WAS LESS RESPONSIVE TO COMMANDS AND BECAME INCREASINGLY HYPOXIC UNTIL RESPIRATORY THERAPY WAS CALLED. THE PATIENT THEN LOST HIS PULSE, WENT INTO CARDIAC ARREST AND REQUIRED INTUBATION. HE WAS ADMITTED TO THE CARDIAC CARE UNIT FOR POST CARDIAC ARREST MANAGEMENT. HIS COURSE WAS COMPLICATED BY OLIGURIC KIDNEY INJURY, METABOLIC/LACTIC ACIDOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2025 WHERE HIS FINAL DIAGNOSIS WAS PERIPHERAL ARTERY DISEASE STATUS POST INTERVENTION COMPLICATED BY CARDIAC ARREST, END STAGE RENAL DISEASE WITH HEMODIALYSIS, AND DYSPHAGIA. THE DYSPHAGIA WAS RELATED TO THE PATIENT'S PROLONGED INTUBATION FOR MECHANICAL VENTILATION. THE PATIENT CONTINUED ON HEMODIALYSIS AFTER HE WAS DISCHARGED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS REPORTED DECEASED BY A FAMILY MEMBER WHEN THE PATIENT WAS AT ANOTHER HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A RECTAL BLEED ON (B)(6) 2025. COLONOSCOPY REVEALED A PERIRECTAL HEMATOMA WHICH WAS CONTROLLED. IN THE OPINION OF THE PHYSICIAN, THE ESPRIT BTK SCAFFOLD IS NOT RELATED TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2884388 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 407126A 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Death