BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 5207888 · Received November 6, 2015

    Report

    Report Number
    2025587-2015-01158
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    September 11, 2015
    Report Date
    November 23, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT HAS NO MEDICAL HISTORY OF STROKE, AND NO HISTORY OF ANTICOAGULANT MEDICATION. EVENT DATE HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED; EVENT DATE IS STILL APPROXIMATE.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE PRODUCT REMAINS IMPLANTED AND IS NOT CURRENTLY AVAILABLE FOR ANALYSIS. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4).

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT DURING POST-PROCEDURE ASSESSMENT, THE PATIENT PRESENTED WITH LEFT SIDE WEAKNESS. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO EVIDENCE OF STROKE. CT PERFUSION WAS NORMAL. CT OF HEAD AND NECK SHOWED 90% SEVERE STENOSIS OF LEFT INTERNAL CAROTID ARTERY. PATIENT REGAINED PARTIAL MOVEMENT OF LEFT SIDE BUT WAS WEAK. DUAL ANTIPLATELET THERAPY WAS ADMINISTERED AND THE PATIENT WAS PLACED ON ONE ON ONE OBSERVATION. THREE DAYS POST-IMPLANT, THE PATIENT EXHIBITED IMPROVED NEUROLOGICAL CONDITION AND STRENGTH, BUT MOTOR IMPERSISTENCE AND NEGLECT ON THE LEFT SIDE REMAINED. ALSO THREE DAYS POST-IMPLANT, THE PATIENT PRESENTED WITH SINUS TACHYCARDIA AND A HEART RATE IN THE 160 BEATS PER MINUTE (BPM) RANGE. MEDICATION WAS ADMINISTERED AND THE ELECTROCARDIOGRAM (ECG) SHOWED THE PATIENT RETURNED TO NORMAL SINUS RHYTHM (NSR). FOUR DAYS POST-IMPLANT, THE PATIENT ORIENTED TO THE PERSON, BUT WAS NOT ORIENTED TO THE CORRECT YEAR. NEUROLOGY NOTED THAT THE PATIENT'S ALTERED MENTAL STATUS IS LIKELY TOXIC METABOLIC ENCEPHALOPATHY. SIX DAYS POST-IMPLANT, THE PATIENT WAS DISCHARGED TO INPATIENT REHAB AND STILL HAD LEFT SIDED NEGLECT. TEN DAYS POST-IMPLANT, AN ECG NOTED THE PATIENT WAS IN ATRIAL FIBRILLATION (AFIB). MEDICATION WAS ADMINISTERED, AND A SUBSEQUENT ECG SHOWED THE PATIENT RETURNED TO NSR. ONE MONTH, NINE DAYS POST-IMPLANT, THE PATIENT RECOVERED FROM CONFUSION. (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 APPROXIMATELY ONE MONTH POST IMPLANT OF THIS BIOPROSTHETIC VALVE IN THE AORTIC POSITION, THE PATIENT MEASURED 18 ON THE NATIONAL INSTITUTE OF HEALTH STROKE ASSESSMENT (NIHSS) SCALE COMPARED TO A BASELINE SCORE OF 0. THIS RATING INDICATES A DECLINE IN HEALTH, INDICATING A MODERATELY SEVERE STROKE. THESE SYMPTOMS WERE REPORTED AS IMPLANT PROCEDURE-RELATED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738922 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305C

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Life Threatening