BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2940235 · Received February 2, 2013

    Report

    Report Number
    2015691-2013-19183
    Event Type
    Injury
    Date Received
    February 2, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE REGURGITATION CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING, BUT NOT LIMITED TO PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. IN THIS CASE, PER THE AVAILABLE MEDICAL RECORDS, IT IS POSSIBLE THAT ENDOCARDITIS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED AORTIC REGURGITATION; HOWEVER, ENDOCARDITIS WAS NOT CONFIRMED AND THE PATIENT WAS SCHEDULED TO RETURN TO THE HOSPITAL FOR A FOLLOW-UP ECHO THREE MONTHS AFTER THE EVENT. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE PARTNERS 1 CLINICAL TRIAL, TWO AND A HALF YEARS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) THE PATIENT EXPERIENCED WORSENING AORTIC REGURGITATION WITH INCREASED SHORTNESS OF BREATH (SOB). PER THE MEDICAL RECORDS, THE PATIENT WAS DIAGNOSED WITH AT LEAST MODERATE TRANS/PARA-VALVULAR BIOPROSTHETIC AORTIC REGURGITATION (AR) WITH HEART FAILURE. POST TAVR, THERE WAS ONLY TRACE AORTIC REGURGITATION (THE ORIGIN OF WHICH APPEARED CENTRAL VIA ECHO). TWO MONTHS PRIOR TO THE EVENT, MILD-MODERATE AR WAS NOTED ON ECHO WITH A TRACE AMOUNT OF PARAVALVULAR REGURGITATION. ONE MONTH PRIOR TO THE EVENT, ECHO REVEALED MODERATE OR MODERATELY-SEVERE AR WITH A SMALL JET OF PARAVALVULAR REGURGITATION. THE ECHO REPORT AT THE TIME OF THE EVENT REVEALED A TRANS-VALVULAR JET OF AR AND THERE APPEARED TO BE A SMALLER PARAVALVULAR JET AS WELL. THE PATIENT WAS NOTED TO HAVE HAD 2 EPISODES OF STAPH BACTEREMIA WITH NO OBVIOUS CARDIAC VEGETATIONS. HOWEVER, DUE TO THE PATIENT'S AR WORSENING POST TAVR THERE WAS A SUSPICION FOR ENDOCARDITIS AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC THERAPY. THE PATIENT WAS SCHEDULED TO RETURN FOR A FOLLOW-UP ECHO IN THREE MONTHS AND IF THE PATIENT'S AR WORSENS OR HER LV FUNCTION DETERIORATES AND THERE IS EVIDENCE OF ACTIVE INFECTION FURTHER INTERVENTION WILL BE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45436 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 2336141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention