BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXNAV DELIVERY SYSTEM

    MDR report key: 20422577 · Received October 10, 2024

    Report

    Report Number
    2135147-2024-04988
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    September 18, 2024
    Report Date
    December 19, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF COMPLETE HEART BLOCK, ASYSTOLE, DISSECTION IN THE COMMON FEMORAL ARTERY, AND HEMORRHAGE WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS.THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL DEFINED MANUFACTURING SPECIFICATIONS. ADDITIONALLY, THE LOT WAS REVIEWED FOR SIMILAR COMPLAINTS, AND THERE IS NO INDICATION OF A LOT-SPECIFIC PRODUCT ISSUE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED COMPLETE HEART BLOCK AND ASYSTOLE COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT PATIENT CONDITIONS (PRE-EXISTING LEFT BUNDLE BRANCH BLOCK (LBBB) AND ATRIAL FIBRILLATION) AND/OR PROCEDURAL CONDITIONS CONTRIBUTED TO THE EVENT; HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED HEMORRHAGE APPEARS TO BE RELATED TO PROCEDURAL COMPLICATION (DISSECTION IN LEFT COMMON FEMORAL ARTERY); HOWEVER, A CAUSE OF THE DISSECTION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED HOSPITALIZATION AND UNEXPECTED MEDICAL INTERVENTION WERE DUE TO CASE-SPECIFIC CIRCUMSTANCES AS A TEMPORARY PACEMAKER WAS PLACED TO ADDRESS THE HEART BLOCK AND ASYSTOLE, A STENT WAS PLACED TO TREAT THE DISSECTION, AND THE PATIENT WAS HOSPITALIZED TO MONITOR THEIR RHYTHM. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM NAVITOR (SERIAL (B)(6)) TRANSCATHETER AORTIC VALVE WAS CHOSEN FOR IMPLANTATION UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM (LOT: 9012348). THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. BASELINE RHYTHM WAS LEFT BUNDLE BRANCH BLOCK AND ATRIAL FIBRILLATION. ONCE THE FLEXNAV CROSSED THE VALVE, THE PATIENT WENT IN TO COMPLETE HEART BLOCK AND BECAME ASYSTOLIC. TEMPORARY PACING WAS STARTED. THE NAVITOR WAS IMPLANTED SUCCESSFULLY AT A DEPTH OF 3MM. WHILE IN THE CUSP OVERLAP VIEW (COV), THE INFLOW EDGE OF THE CONSTRAINED VALVE WITHIN THE CAPSULE WAS POSITIONED AT THE BASE OF AORTIC ANNULUS WHILE THE PIGTAIL POSITIONED WAS CONFIRMED TO BE AT THE BOTTOM OF THE NON CORONARY CUSP (NCC). AFTER REMOVAL OF THE FLEXNAV, A LEFT GROIN DISSECTION WAS OBSERVED. A COVERED STENT WAS PLACED TO TREAT THE DISSECTION. THE PATIENT LEFT THE OPERATING ROOM WITH TEMPORARY PACING AND WAS HOSPITALIZED FOR MONITORING OF RHYTHM. ON (B)(6) 2024, A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM NAVITOR (SERIAL (B)(6)) TRANSCATHETER AORTIC VALVE WAS CHOSEN FOR IMPLANTATION UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM (LOT: 9012348). THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. BASELINE RHYTHM WAS LEFT BUNDLE BRANCH BLOCK AND ATRIAL FIBRILLATION. ONCE THE FLEXNAV CROSSED THE VALVE, THE PATIENT WENT ASYSTOLIC. TEMPORARY PACING WAS STARTED. THE NAVITOR WAS IMPLANTED SUCCESSFULLY AT A DEPTH OF 3MM. WHILE IN THE CUSP OVERLAP VIEW (COV), THE INFLOW EDGE OF THE CONSTRAINED VALVE WITHIN THE CAPSULE WAS POSITIONED AT THE BASE OF AORTIC ANNULUS WHILE THE PIGTAIL POSITIONED WAS CONFIRMED TO BE AT THE BOTTOM OF THE NON CORONARY CUSP (NCC). AFTER REMOVAL OF THE FLEXNAV, A LEFT GROIN DISSECTION WAS OBSERVED. A COVERED STENT WAS PLACED TO TREAT THE DISSECTION. THE PATIENT LEFT THE OPERATING ROOM WITH TEMPORARY PACING AND WAS HOSPITALIZED FOR MONITORING OF RHYTHM. ON (B)(6) 2024, A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313399 FLEXNAV DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL 9012348

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Required Intervention LARGE FLEXNAV DELIVERY SYSTEM| NAVITOR VALVE, NVTR-27, SN 19913691