BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 20015375 · Received August 21, 2024

    Report

    Report Number
    2024168-2024-09781
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 5, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357138
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 OTHER INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED THAT THE ESPRIT BTK SYSTEM INSTRUCTION FOR USE (IFU) STATES: USING FLUOROSCOPIC VISUALIZATION, DEPLOY THE SCAFFOLD SLOWLY, BY PRESSURIZING THE DELIVERY SYSTEM IN 2-ATM INCREMENTS OVER 5 SECONDS, UNTIL THE SCAFFOLD IS COMPLETELY EXPANDED. THE INVESTIGATION COULD NOT DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED MATERIAL RUPTURE. THE REPORTED DIFFICULT/DELAYED ACTIVATION OF THE SCAFFOLD APPEARS TO BE RELATED TO THE USER ERROR OF RAPID INFLATION OF THE SCAFFOLD. THE REPORTED TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED. H6 - MEDICAL DEVICE PROBLEM CODE 2017 CLARIFIER: FAILURE TO FOLLOW STEPS / INSTRUCTIONS. 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 AN OSTIAL ANTERIOR TIBIAL (AT) LESION. ORBITAL ATHERECTOMY WAS PERFORMED TO PREPARE THE LESION. THE 3.75X18MM ESPRIT BTK SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. THE SYSTEM WAS INFLATED TO 12 ATMOSPHERES (ATM) WITHIN 7 SECONDS WHEN IT WAS NOTED THE BALLOON RUPTURED. THE INDEFLATOR WAS PRESSURIZED RAPIDLY IN AN ATTEMPT TO GET ANY ADDITIONAL LUMINAL GAIN. THE ESPRIT SYSTEM WAS REMOVED AND THE VIPERWIRE REMAINED IN PLACE. A 4.0X150MM NON-ABBOTT BALLOON DILATATION CATHETER WAS ADVANCED TO THE ESPRIT SCAFFOLD WHICH WAS LOCATED PROXIMALLY IN THE DISTAL POPLITEAL INTO THE OSTIAL AT. THE BALLOON WAS INFLATED QUICKLY TO 6ATM TO MAKE SURE IF ANYTHING WAS MOBILE, IT WOULD BE STABILIZED, THEN SLOWLY TO 12 ATM AND HELD FOR 1.5 MINUTES. THE BALLOON WAS REMOVED WITH NO DIFFICULTY. THE ESPRIT LOCATION WAS VERIFIED UNDER FLUORO. THE VIPERWIRE WAS REMOVED FROM THE AT AND REPOSITIONED IN THE TIBIO-PERONEAL TRUNK (TPT). A NAVICROSS 035 SUPPORT CATHETER WAS ADVANCED INTO THE TPT WITH NO RESISTANCE FELT; HOWEVER ON ANGIO IT WAS VISUALLY NOTED THE ESPRIT MARKER ¿FLEXED¿ DOWN TOWARDS THE TPT. THE CATHETER WAS PULLED BACK AND THEN READVANCED. NO ¿BOWING¿ OF THE ESPRIT MARKER WAS NOTED. THE PRESSURE GRADIENT WAS ASSESSED TO BE NORMAL; HOWEVER THE MARKER REMAINED ¿BOWED¿ IN APPEARANCE. THE SAME NON-ABBOTT BALLOON CATHETER WAS ADVANCED INTO THE TPT AND INFLATED TO 4 ATM AND PULLED UP WHILE INFLATED TO GET THE SCAFFOLD BACK TO ORIGINAL CONFORMATION. THE BALLOON WAS DEFLATED AND NO GRADIENT WAS NOTED. THE FINAL PICTURE ¿APPEARED GOOD WITH 3 VESSEL FLOW.¿ THE ENTIRE PROCEDURE WAS DELAYED 45 MINUTES. THE PATIENT WAS DISCHARGED LATER THAT DAY. APPROXIMATELY TWO WEEKS POST PROCEDURE THE PATIENT WAS REASSESSED AND DOING GREAT. PER THE PHYSICIAN, THERE WAS NOT A FAILURE OF THE DEVICE BUT RATHER USER ERROR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116755 ESPRIT¿ STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. 1203375-18 4032861 08717648357138

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention