BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3729004 · Received April 7, 2014

    Report

    Report Number
    2015691-2014-00787
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AWARE DATE WAS INADVERTENTLY NOTED AS 02/12/2014. ACTUAL AWARE DATE WAS 03/17/2014. ECHO IMAGES WERE SUBMITTED TO EDWARDS FOR REVIEW, NO CINE WAS PROVIDED. THE FOLLOWING OBSERVATIONS/CONCLUSIONS WERE MADE BY (B)(4): OBSERVATIONS: 8 DAYS PRIOR TO TAVR- TEE DEMONSTRATES A SEVERELY CALCIFIED TRI-LEAFLET VALVE WITH CALCIUM MORE PRONOUNCED ON THE NCC THAN ON THE LCC, AND MUCH GREATER THAN ON THE RCC. DAY OF TAVR PROCEDURE- THERE WAS SEVERE AORTIC VALVE CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA. TEE DEMONSTRATES A WELL POSITIONED XT VALVE WITH SEVERE CENTRAL AORTIC REGURGITATION (AR). THE APPEARANCE OF THE XT LEAFLETS MAY BE THICKENED, HOWEVER, DUE TO COLOR FLOW IMAGING IS DIFFICULT TO PRECISELY ANALYZE. FURTHERMORE, THE PRESENCE OF NATIVE LEAFLET OVERHANG WHICH MAY LEAD TO CENTRAL AORTIC INSUFFICIENCY (CAI) CANNOT BE DEFINITIVELY EXCLUDED. ALTHOUGH THE PRESENCE OF NATIVE LEAFLET OVERHANG IS UNLIKELY IN THIS CASE. 3 MONTHS POST TAVR- TEE MID-ESOPHAGEAL SHORT AXIS VIEW DEMONSTRATES THICKENING OF ALL 3 XT CUSPS, CONSISTENT WITH FIBROSIS. ON MID-ESOPHAGEAL LONG AXIS VIEW IT IS DIFFICULT TO RULE OUT NATIVE LEAFLET OVERHANG GIVEN THE IMAGES PROVIDED. HOWEVER, THE VALVE LEAFLETS DUE APPEAR THICKENED AND FIBROTIC. IMPRESSIONS: THE APPEARANCE OF THE XT VALVE AFTER DEPLOYMENT ON THE DAY OF THE INITIAL PROCEDURE DEMONSTRATES SLUGGISH LEAFLET MOTION WITH THICKENING OF ALL 3 CUSPS, IN THE PRESENCE OF A SEVERE CENTRAL LEAK. TEE FROM 3 MONTHS LATER DEMONSTRATES PROGRESSION. IT IS UNCLEAR FROM THESE IMAGES WHAT THE ETIOLOGY OF THESE CHANGES TO THE XT LEAFLETS WERE CAUSED BY. ALTHOUGH NATIVE LEAFLET OVERHANG CANNOT BE EXCLUDED, IT SEEMS UNLIKELY IN THIS CASE. IT WOULD BE USEFUL TO GAIN FURTHER UNDERSTANDING OF THE PATIENT¿S STATE OF ANTI-COAGULATION (FOR EXAMPLE, ACT) AND WHETHER A HYPERCOAGULABLE STATE EXISTED. WITH REGARD TO THE INDEX PROCEDURE, EDWARDS WAS NOT MADE AWARE OF A NON-FUNCTIONING OR RESTRICTED LEAFLET, OR RESIDUAL REGURGITATION AT THE END OF THE PROCEDURE. WITH THE INFORMATION AVAILABLE THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL ACTIONS ARE WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ECHO IMAGES WERE SUBMITTED TO EDWARDS FOR REVIEW, NO CINE WAS PROVIDED. THE FOLLOWING OBSERVATIONS/CONCLUSIONS WERE MADE BY THE EDWARDS MEDICAL DIRECTOR: OBSERVATIONS: 8 DAYS PRIOR TO TAVR- TEE DEMONSTRATES A SEVERELY CALCIFIED TRI-LEAFLET VALVE WITH CALCIUM MORE PRONOUNCED ON THE NCC THAN ON THE LCC, AND MUCH GREATER THAN ON THE RCC. DAY OF TAVR PROCEDURE- THERE WAS SEVERE AORTIC VALVE CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA. TEE DEMONSTRATES A WELL POSITIONED XT VALVE WITH SEVERE CENTRAL AORTIC REGURGITATION (AR). THE APPEARANCE OF THE XT LEAFLETS MAY BE THICKENED, HOWEVER, DUE TO COLOR FLOW IMAGING IS DIFFICULT TO PRECISELY ANALYZE. FURTHERMORE, THE PRESENCE OF NATIVE LEAFLET OVERHANG WHICH MAY LEAD TO CENTRAL AORTIC INSUFFICIENCY (CAI) CANNOT BE DEFINITIVELY EXCLUDED. ALTHOUGH THE PRESENCE OF NATIVE LEAFLET OVERHANG IS UNLIKELY IN THIS CASE.

    Description of Event or Problem · 1

    ALMOST 3 MONTHS POST IMPLANT OF A SAPIEN VALVE, THE PATIENT PRESENTED WITH A SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI). DURING THE WORKUP FOR THE CAI, THE PATIENT WAS FOUND TO HAVE METASTATIC CANCER, WHICH THEY WERE UNAWARE OF PRIOR TO THE WORKUP. IT WAS INDICATED THAT THE PATIENT HAD TRI-LEAFLET FIBROSIS, WHICH WAS CAUSING THE SEVERE AI. THEY DID NOT KNOW WHAT WAS CAUSING THE FIBROSIS. NO RE-INTERVENTION WAS PERFORMED. THE PATIENT WAS PLACED INTO HOSPICE, AND ULTIMATELY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206131 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention