BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 19962641 · Received August 12, 2024

    Report

    Report Number
    2024168-2024-09478
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) AND LOT LEVEL SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED PATIENT EFFECT OF THROMBOSIS 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.

    Additional Manufacturer Narrative · 0

    D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY. THE PATIENT HAD PREVIOUSLY DONE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) A FEW MONTHS PRIOR, AND THE PATIENT RE-PRESENTED WITH POOR WOUND HEALING. RESTENOSIS AND RECOIL WAS NOTED IN THE ANTERIOR TIBIAL (AT) ARTERY AT A CALCIFIED PORTION. THIS WAS TREATED WITH PTA AND SHOCKWAVE. RECOIL WAS NOTED. THE LESION WAS VERY CHALLENGING THEREFORE THREE ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN OVERLAPPING FASHION. A FEW DAYS LATER THE PATIENT WAS BROUGHT BACK TO THE CATH LAB DUE TO POOR WOUND HEALING; THE VESSEL HAD CLOSED DUE TO THROMBUS. THE THROMBUS WAS TREATED WITH BALLOON INFLATIONS AND A STENT IMPLANT. PER THE PHYSICIAN, AFTER THE INITIAL IMPLANT THE PATIENT HAD GOOD FLOW AND OUTFLOW THROUGH THE SCAFFOLDS THEREFORE THE THROMBUS WAS NOT DUE TO THE ESPRIT BTK SCAFFOLDS. HE THINKS ANY TREATMENT WOULD HAVE BEEN CHALLENGED IN THIS SITUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265613 ESPRIT¿ STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. UNK ESPRIT BTK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R