BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS

    MDR report key: 9262625 · Received October 31, 2019

    Report

    Report Number
    2015691-2019-04047
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    September 27, 2018
    Report Date
    October 9, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWQ
    PMA / PMN Number
    P870038/S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. WITHOUT ADDITIONAL INFORMATION THE CAUSE OF THE EVENT REMAINS INDETERMINABLE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ARTICLE "USE OF MECHANICAL VALVE PROSTHESES IN ADULTS WITH TETRALOGY OF FALLOT" INTERNATIONAL JOURNAL OF CARDIOLOGY 291 (2019) 45-49. HTTPS://DOI.ORG/10.1016/J.IJCARD.2019.02.028. BACKGROUND: THERE ARE LIMITED DATA ABOUT THE OUTCOMES MECHANICAL PROSTHESES IN ADULTS WITH TETRALOGY OF FALLOT (TOF). THE PURPOSE OF THE STUDY WAS TO DESCRIBE THE INCIDENCE OF MECHANICAL VALVE RELATED ADVERSE EVENTS (MVRAE), REOPERATION AND ALL-CAUSE MORTALITY IN TOF PATIENTS WITH MECHANICAL VALVE PROSTHESES. METHODS: WE REVIEWED THE MACHD (MAYO ADULT CONGENITAL HEART DISEASE) DATABASE AND IDENTIFIED ALL ADULT TOF PATIENTS WITH MECHANICAL VALVE PROSTHESES, 1990¿2017. MVRAE WAS DEFINED AS VALVE THROMBOSIS, ENDOCARDITIS, EMBOLIC STROKE OR MAJOR BLEEDING COMPLICATIONS. RESULTS: A TOTAL OF 44 PROSTHESES WERE IMPLANTED IN 29 PATIENTS (AGE 44±13 YEARS; MEN 18 [62%]), AND 10 (36%) PATIENTS RECEIVED MULTIPLE MECHANICAL PROSTHESES. THE MEDIAN NUMBER OF PRIOR STERNOTOMIES WAS 3 (RANGE 2¿7). TARGET INTENTIONAL NORMALIZED RATIO (INR)WAS 2.0¿3.0 FOR PATIENTS WITH ISOLATED MECHANICAL AORTIC PROSTHESES (N= 12, 41%), 2.5¿4.0 FOR MECHANICAL PROSTHESES IN NON-AORTIC POSITIONS. THERE WERE NO SURGICAL DEATHS, AND 10 MVRAE (ENDOCARDITIS [N = 4], MAJOR BLEEDING COMPLICATIONS [N = 5] AND VALVE THROMBOSIS [N= 1]) OCCURRED IN 7 (24%) PATIENTS DURING A MEDIAN FOLLOW-UP OF 11 (5 18) YEARS. THE 10-YEAR SURVIVAL AND FREEDOM FROM REOPERATION WERE 87% AND 95% RESPECTIVELY. CONCLUSIONS: SURGICAL MORTALITY AND VALVE THROMBOSIS FOR MECHANICAL VALVE PROSTHESES ARE LOW PRESUMABLY DUE TO APPROPRIATE PATIENT SELECTION AND METICULOUS ANTICOAGULATION. ENDOCARDITIS AND BLEEDING COMPLICATIONS ARE MAJOR CONCERNS. FURTHER STUDIES ARE REQUIRED TO DETERMINE THE APPROPRIATE TARGET INR THAT PROVIDES THE OPTIMAL BALANCE BETWEEN PREVENTING VALVE THROMBOSIS AND AVOIDING MAJOR BLEEDING COMPLICATIONS MECHANICAL VALVE PROSTHESES IN DIFFERENT POSITIONS. THIS CASE IS FOR:A 10A STARR-EDWARDS MECHANICAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 29 YEARS DUE TO UNKNOWN REASONS. IT WAS REPORTED THE PATIENT WAS (B)(6) YEARS OLD AT TIME EXPLANT. PATIENT HAD AORTIC VALVE EXPLANTED AT THE TIME OF THE PULMONARY VALVE REPLACEMENT. THE STARR-EDWARDS VALVE WAS ORIGINALLY IMPLANTED DUE TO BICUSPID AORTIC VALVE AND AORTIC REGURGITATION. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM CARBOMEDICS MECHANICAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057746 STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS HEART-VALVE, MECHANICAL LWQ EDWARDS LIFESCIENCES 1260A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R