BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 19886947 · Received August 1, 2024

    Report

    Report Number
    2024168-2024-09110
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    June 6, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357237
    PMA / PMN Number
    P230036
    Product Problem
    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 RETURNED FOR ANALYSIS. THE REPORTED DEFORMATION DUE TO COMPRESSIVE STRESS WAS CONFIRMED THROUGH A SUPPORT WIRE BREAK AND OUTER MEMBER DAMAGE. THE REPORTED FAILURE TO ADVANCE, DIFFICULTY TO ADVANCE AND MATERIAL TOO RIGID OR STIFF COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED STIFFNESS OF THE DEVICE IS A PERSONAL OPINION/PREFERENCE OF THE PHYSICIAN AND NOT A QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PERONEAL ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A 6FR X 45 CM SHEATH AND A 0.014¿ NON-ABBOTT GUIDEWIRE WAS USED IN THE CASE. THE PHYSICIAN ACCESSED THE ANATOMY THROUGH THE RIGHT GROIN AND WENT UP AND OVER THE ILIAC ARCH TO THE LEFT SIDE. IVUS (INTRAVASCULAR ULTRASOUND) WAS USED TO VISUALIZE THE SUPERFICIAL FEMORAL ARTERY (SFA) AND A DRUG COATED BALLOON (DCB) WAS ADVANCED TO THE SFA. ANOTHER IVUS RUN WAS COMPLETED AFTER THE INFLATION OF THE DCB AND EVERYTHING LOOKED GOOD. THE TARGET LESION WAS IN THE PERONEAL ARTERY AND WAS PRE-DILATED WITH A BALLOON DILATATION CATHETER. THE ESPRIT BTK EVEROLIMUS ELUTING BIORESORBABLE SCAFFOLD SYSTEM WAS PREPPED AND INSERTED. THE PHYSICIAN COMMENTED THAT THE DEVICE FELT STIFF AND THERE WAS SOME RESISTANCE EXPERIENCED WHEN ADVANCING. THE DEVICE WAS ADVANCED UP AND OVER THE ILIAC ARCH, BUT ONCE ON THE OTHER SIDE, THERE WAS RESISTANCE AND THE DELIVERY SYSTEM WAS PUSHING THE SHEATH BACK TOWARDS THE AORTA. THE SDS WOULD NOT GO OVER THE ILIAC ARTERY. AFTER MULTIPLE ATTEMPTS, THE SDS WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUE. THE PROCEDURE WAS ENDED. WHEN THE SDS WAS REMOVED FROM THE BODY, A KINK AT THE GUIDEWIRE EXIT NOTCH WAS OBSERVED. DEVICE ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE BAYONET/SUPPORT WIRE WAS SEPARATED 1.5CM DISTAL TO THE OUTER MEMBER TO HYPOTUBE BOND BUT HELD TOGETHER BY THE SHAFT. THE OUTER MEMBER WAS TORN AT THE SAME LOCATION OF THE SEPARATED BAYONET/ SUPPORT WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985200 ESPRIT¿ STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. 1203250-28 4040461 08717648357237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: 0.014¿ GLIDEWIRE ADVANTAGE.| SHEATH: 6F, 45 CM DESTINATION (TERUMO).