BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT BTK RX IDE

    MDR report key: 19766561 · Received July 17, 2024

    Report

    Report Number
    2024168-2024-08480
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 12, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648234064
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. 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. THE REPORTED PATIENT EFFECTS OF STENOSIS IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY SCAFFOLD PROCEDURES. 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. B2: OUTCOMES ATTRIBUTED TO AE: CORRECTED FROM OTHER SERIOUS TO HOSPITALIZATION-INITIAL OR PROLONGED, REQUIRED INTERVENTION. B5: DESCRIBE EVENT OR PROBLEM WAS UPDATED AND THE STUDY NAME WAS CORRECTED FROM (B)(6) STUDY REPORT TO (B)(6). H6: ADVERSE EVENT PROBLEM HEALTH EFFECT - IMPACT CODE 4614 WAS REMOVED.

    Additional Manufacturer Narrative · 0

    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

    (B)(6). SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE PATIENT CONTINUED TO HAVE BILATERAL LOW EXTREMITY PAIN AFTER WALKING FOR 3 TO 4 BLOCKS. ON (B)(6) 2024, REVASCULARIZATION USING VARIOUS METHODS SUCH AS, DRUG COATED BALLOON ANGIOPLASTY AND LASER ATHERECTOMY WAS PERFORMED IN THE LEFT POSTERIOR TIBIAL, POPLITEAL ARTERY, AND SUPERFICIAL FEMORAL ARTERY. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    CRD_907 ILUMIEN IV STUDY REPORT. PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021 THE 3.X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT PROXIMAL POSTERIOR TIBIAL ARTERY. ON (B)(6) 2024, THE PATIENT WAS SEEN FOR THE THREE YEAR FOLLOW-UP VISIT AND REPORTED HAVING BILATERAL LOWER EXTREMITY PAIN AFTER WALKING FOR 3 TO 4 BLOCKS. THIS WAS DOCUMENTED AS LOWER LIMB ARTERIAL OCCLUSION. RECOVERY FROM THE PAIN TAKES THREE MINUTES. ALTHOUGH THE PHYSICIAN HAS INDICATED THAT THE PAIN AND OCCLUSION IN THE LOWER EXTREMITIES ARE NOT RELATED TO THE SCAFFOLD, THE PATIENT WAS NOTED TO HAVE 50 TO 75% IN-STENT TARGET LESION STENOSIS ON DUPLEX ULTRASOUND. NO TREATMENT HAS BEEN PERFORMED AS OF THIS TIME. THE PATIENT MET WITH THE PHYSICIAN TO DISCUSS REINTERVENTION DATES ON (B)(6) 2024, BUT THE DATE OF UPCOMING TREATMENT IS PENDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352261 ESPRIT BTK RX IDE STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. 1202300-38 10222P5 08717648234064

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other| H| R