BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE

    MDR report key: 9557902 · Received January 7, 2020

    Report

    Report Number
    3007113487-2019-00039
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    December 11, 2019
    Report Date
    February 18, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    LWQ
    UDI-DI
    05415067016522
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF LEAFLET IMMOBILITY AND INCREASE OF GRADIENT DUE TO POSSIBLE THROMBUS IN A PATIENT WITH MULTIPLE CONCOMITANT INFECTIONS DUE TO COMORBIDITIES AND SUSPECTED ENDOCARDITIS WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE 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 SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    AFTER MHV IMPLANTATION ON (B)(6) 2019 OF A 15MHPJ-505 (SN (B)(6) ) UNDER COMPASSIONATE USE (BEFORE CE MARK), IT WAS DETECTED ON (B)(6) 2019 A BLOCK IN ONE OF THE LEAFLETS (NOT MOVING), AFTER DETECTION OF LOW PATIENT OUTPUT AND INCREASE OF GRADIENTS. ANTITROMBOTIC THERAPY WAS INTRODUCED WITHOUT SUCCESS FACING A POSSIBLE THROMBUS. THE PATIENT WASN¿T UNDER AC SINCE INTERVENTION BECAUSE OF VERY YOUNG AGE AND MULTIPLE COMORBIDITIES. THE PATIENT HAD BEEN UNDER LOW MOLECULAR WEIGHT HEPARYN. THE PATIENT HAS HAD LOT OF CONCOMITANT INFECTIONS DUE TO COMORBIDITIES. SURGEONS SUSPECT ON ENDOCARDITIS. THE PROSTHESIS HAS BEEN EXPLANTED TODAY (B)(6) ) AND SENT BY THE SURGEONS TO THE MICROBIOLOGY LAB AT THEIR HOSPITAL FOR ANALYSIS. THEY HAVE IMPLANTED ANOTHER ABBOTT 15MMS.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    AFTER MHV IMPLANTATION ON (B)(6) 2019 OF A 15MHPJ-505 (SN (B)(4)) UNDER COMPASSIONATE USE (BEFORE CE MARK), IT WAS DETECTED ON (B)(6) 2019 A BLOCK IN ONE OF THE LEAFLETS (NOT MOVING), AFTER DETECTION OF LOW PATIENT OUTPUT AND INCREASE OF GRADIENTS. ANTITHROMBOTIC THERAPY WAS INTRODUCED WITHOUT SUCCESS FACING A POSSIBLE THROMBUS. THE PATIENT WASN'T UNDER AC SINCE INTERVENTION BECAUSE OF VERY YOUNG AGE AND MULTIPLE COMORBIDITIES. THE PATIENT HAD BEEN UNDER LOW MOLECULAR WEIGHT HEPARYN. THE PATIENT HAS HAD LOT OF CONCOMITANT INFECTIONS DUE TO COMORBIDITIES. SURGEONS SUSPECT ON ENDOCARDITIS. THE PROSTHESIS HAS BEEN EXPLANTED TODAY ((B)(6)) AND SENT BY THE SURGEONS TO THE MICROBIOLOGY LAB AT THEIR HOSPITAL FOR ANALYSIS. THEY HAVE IMPLANTED ANOTHER ABBOTT 15MMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24258 SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL CATD 15MHPJ-505 5328893 05415067016522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention