BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 6172531 · Received December 13, 2016

    Report

    Report Number
    2015691-2016-03696
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 23, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE PATIENT'S THREE (3) YEAR FOLLOW-UP, TTE SHOWED TRIVIAL AORTIC REGURGITATION. THE PEAK GRADIENT WAS 77 MMHG AND A MEAN GRADIENT OF 42 MMHG. THE PATIENT DENIES EXPERIENCING ANY ER VISITS, HOSPITALIZATIONS OR ADVERSE EVENTS SINCE HER DISCHARGE. THE PLAN IS TO CONTINUE MONITORING THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS, MODEL# 3300TFX, PMA# 860057/S042. (B)(4). ADDITIONAL MANUFACTURER NARRATIVE: STENOSIS OF AN IMPLANTED VALVE MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION WHICH CAN ENCOMPASS MULTIPLE FAILURE MODES. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT. AT THIS TIME, EDWARDS LIFESCIENCES IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT OR CONFIRM THE CLINICAL OBSERVATION. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT PROSTHESIS MISMATCH (PPM) IS PRESENT WHEN THE EFFECTIVE ORIFICE AREA OF THE INSERTED PROSTHETIC VALVE IS TOO SMALL IN RELATION TO BODY SIZE. ITS MAIN HEMODYNAMIC CONSEQUENCE IS TO GENERATE HIGHER THAN EXPECTED GRADIENTS THROUGH A NORMALLY FUNCTIONING PROSTHETIC VALVE. IN THIS CASE, THE SITE INDICATES THE VALVE HAS HIGH GRADIENTS WITH MILD REGURGITATION. AT THIS TIME, THERE HAS BEEN NO SURGICAL INTERVENTION. REGURGITATION WHICH IS DETECTED BY ECHOCARDIOGRAM WITH NO INDICATION FOR INTERVENTION SUGGESTS THE DEVICE CONTINUES TO PERFORM ITS ESSENTIAL FUNCTION. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE IS FAILING AFTER APPROXIMATELY TWO (2) YEARS DUE TO SEVERE AORTIC STENOSIS, WHICH WAS DETECTED ON ECHOCARDIOGRAM. AS REPORTED, THE ISSUE IS NOTED AS ONGOING AND SURGICAL INTERVENTION TO EXPLANT/REPLACE THE VALVE HAS NOT BEEN PERFORMED, AT THIS TIME. MEDICAL INTERVENTION WAS NOTED; HOWEVER, THE TYPE OF TREATMENT IS UNCLEAR.

    Description of Event or Problem · 1

    PER ECHO RESULTS PERFORMED THREE (3) DAYS POST INITIAL IMPLANTATION OF THIS VALVE, HIGH GRADIENTS WERE OBSERVED; HOWEVER, THE VALVE APPEARED WELL SEATED AND OPENED NORMALLY. FINDINGS SUGGESTED PATIENT-PROSTHESIS MIS-MATCH. ECHOCARDIOGRAM APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION REVEALED MILD (+1) AORTIC VALVE REGURGITATION, PEAK GRADIENT IS 71 MMHG, MEAN GRADIENT IS 45 MMHG. AT THIS TIME, THERE HAS BEEN NO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822338 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR