BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC 23MM

    MDR report key: 3686547 · Received March 18, 2014

    Report

    Report Number
    2025587-2014-00131
    Event Type
    Injury
    Date Received
    March 18, 2014
    Date of Event
    December 31, 2013
    Report Date
    April 9, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE SERIAL NUMBER WAS NOT PROVIDED. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF MEDTRONIC'S DATABASE DID NOT FIND ANY PREVIOUS REPORTS OR RECORDS OF THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ARTICLE AUTHORS' DESIGNATED CONTACT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED OR WHEN THE INVESTIGATION IS COMPLETED. JOURNAL OF CARDIAC SURGERY, 2013, 28:723-729; 10.1111/JOCS.12181.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A MEDICAL JOURNAL ARTICLE THAT AN AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED APPROXIMATELY SEVEN MONTHS AFTER IMPLANT AFTER THE (B)(6) OLD MALE PATIENT DEVELOPED SYMPTOMS OF LEFT VENTRICULAR IMPAIRMENT WHICH LED TO HOSPITALIZATION FOR NONINVASIVE VENTILATION SUPPORT. EXAMINATION REVEALED THE PRESENCE OF AN EJECTION SYSTOLIC MURMUR, AND AN ECHOCARDIOGRAPH SHOWED HIGH GRADIENTS AND A REDUCED EFFECTIVE ORIFICE AREA. THE PATIENT'S LEFT VENTRICULAR FUNCTION HAD ALSO DETERIORATED WITH A 40% EJECTION FRACTION. THE VALVE WAS EXPLANTED; UPON EXPLANT, SIGNIFICANT THROMBOTIC DEPOSITS WERE OBSERVED ON THE AORTIC SURFACES OF ALL THREE LEAFLETS AND LEAFLET OPENING WAS RESTRICTED. THE VALVE WAS REPLACED WITH A NON-MEDTRONIC XENOGRAFT AORTIC VALVE (23 MM). HOSPITAL HISTOLOGY CONFIRMED THE PRESENCE OF THE THROMBOTIC DEPOSITS. THE HOSPITAL ANALYSIS NOTED THERE WAS NO EVIDENCE OF BACTERIOLOGICAL GROWTH OR EVIDENCE OF ORGANISMS, AND RADIOLOGY DID NOT SHOW EARLY CALCIFICATION. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY PREVIOUS HISTORY OF THROMBOEMBOLIC COMPLICATIONS AND HAD A NORMAL ANTICOAGULANT SCREEN. THE JOURNAL ARTICLE DISCUSSED CURRENT ANTICOAGULATION RECOMMENDATIONS FOR BIOPROSTHETIC AORTIC VALVE REPLACEMENT, AND THE POSSIBLE ASSOCIATED INCREASED THROMBOEMBOLIC RISK. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161799 HANCOCK II AORTIC 23MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505-23H

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention