BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 4103268 · Received September 19, 2014

    Report

    Report Number
    2025587-2014-00683
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    November 14, 2012
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE RECEIVED INFORMATION, THE FAILURE MODE COULD NOT BE DETERMINED. WITHOUT THE RETURN OF THE VALVE, A ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE OPERATIVE REPORT FOR THE EXPLANT PROCEDURE SUBSEQUENTLY WAS PROVIDED. THE PATIENT¿S MEDICAL HISTORY INCLUDED MULTIPLE HEART SURG ERIES RELATED TO A COMPLEX CARDIAC HISTORY OVER 26 YEARS (INCLUDING DECORTICATION REPAIR, AN AORTIC VALVE COMMISSUROTOMY AND A REPEAT COMMISSUROTOMY, AND AORTIC ENLARGEMENT). THIS DEVICE WAS INITIALLY IMPLANTED TO REPLACE THE NATIVE AORTIC VALVE. FOLLOWING DEVICE IMPLANT, THE PATIENT DEVELOPED A FISTULA BETWEEN THE LEFT VENTRICULAR OUTFLOW TRACT AND RIGHT ATRIUM, WHICH WAS SURGICALLY CORRECTED THREE MONTHS LATER. EVALUATION SHOWED THE VALVE WAS STABLE WITH LEAFLET MOTION; HOWEVER, A JET ACROSS THE VALVE WAS OBSERVED IN THE PROXIMAL AORTIC ROOT. FURTHER EXAMINATION INDICATED AN UNUSUAL CONFIGURATION TO THE NATIVE ROOT; THE ROOT AND AORTA WERE RELATIVELY SMALL IN SIZE WITH NARROWING AT THE SINOTUBULAR JUNCTION. THE CORONARY ARTERIES SHOWED NO OBVIOUS STENOSIS, BUT IT WAS NOTED THAT THE RIGHT AND LEFT CORONARY ARTERY WERE A SINGLE CONTINUOUS FLOW LOOP VESSEL WITH BRANCHES COMING OFF THEM (WHEN THE RIGHT ARTERY WAS INJECTED, FLOW WAS OBSERVED IN BOTH DIRECTIONS DISTALLY; WHEN THE LEFT ARTERY WAS INJECTED, THE RIGHT MAIN CORONARY ARTERY FILLED). IT WAS DETERMINED THAT THERE MAY BE SOME COMPONENT OF CORONARY INSUFFICIENCY THAT WAS RELATED TO THE POSITION OF THIS DEVICE, AND BASED ON THE OBSERVATIONS, IT WAS DETERMINED THAT THE ENTIRE ROOT SHOULD BE REPLACED, WITH A NEW VALVE REPLACEMENT ALSO. THE PATIENT ELECTED TO HAVE A TISSUE VALVE, SO THE REPLACEMENT WAS PERFORMED WITH AN AORTIC ROOT BIOPROSTHESIS. POST-PROCEDURE HEMODYNAMICS WERE REPORTED AS EXCELLENT, AND A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED GOOD VALVE FUNCTION WITH NO ANOMALIES OBSERVED. UPDATED/CORRECTED INFORMATION: THE EVENT DATE IS CHANGED TO THE DEVICE EXPLANT DATE, WHICH WAS NOT PREVIOUSLY AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF MEDTRONIC¿S DATABASE SHOWED THERE HAVE BEEN NO PREVIOUS REPORTS REGARDING THIS DEVICE AND NO RECORD OF IT HAVING BEEN RETURNED FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION IS OBTAINED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS DEVICE LIKELY WAS EXPLANTED APPROXIMATELY 37 MONTHS AFTER ITS IMPLANT. A HEALTH CARE FACILITY CONTACTED MEDTRONIC TECHNICAL SERVICES TO REQUEST MAGNETIC RESONANCE IMAGING COMPATIBILITY INFORMATION FOR THE PATIENT¿S BIOPROSTHETIC DEVICE. A DISCREPANCY WAS NOTED IN THE INFORMATION FOR THE PATIENT¿S REPORTED CURRENT DEVICE AND THE DEVICE REGISTERED TO HIM. MEDTRONIC TECHNICAL SERVICES SUBSEQUENTLY SPOKE WITH THE PATIENT, WHO REPORTED THE DEVICE HAD BEEN INSTALLED CROOKED. THE PATIENT¿S IMPLANTING PHYSICIAN¿S OFFICE IS WORKING THE FACILITY¿S MEDICAL RECORDS DEPARTMENT TO TRY TO OBTAIN ADDITIONAL DETAILS. THE HEALTH CARE FACILITY REPORTED THAT THE PATIENT HAS HAD MULTIPLE HEART SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581720 MOSAIC HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305U25

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention