BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3011864 · Received March 19, 2013

    Report

    Report Number
    2015691-2013-19594
    Event Type
    Death
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT IS ONGOING. THIS REPORT IS ASSOCIATED WITH MEDWATCH REPORTS 2015691-2013-19590 AND 2015691-2013-19591.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER SAPIEN VALVE PERFORMANCE WILL BE IMPAIRED. IMAGING REVIEW DETERMINED THAT THE TTE PERFORMED ON (B)(6) 2012 AND (B)(6) 2013 REVEALED THE PRESENCE OF SIGNIFICANT CENTRAL (TRANSVALVULAR) AR. THE EXACT ETIOLOGY OF THE AR CANNOT BE ASCERTAINED DUE TO IMPERFECT IMAGE QUALITY, HOWEVER, THE POSSIBILITY OF LEAFLET OVERHANG FROM THE INITIAL SAPIEN VALVE SHOULD BE CONSIDERED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION, THE OFFICIAL CAUSE OF DEATH REMAINS UNKNOWN; HOWEVER, THE REPORT OF WORSENING CENTRAL AI MAY HAVE CONTRIBUTED TO THAT OUTCOME. IN ADDITION, A BOWEL EMBOLIZATION WAS ALSO CONSIDERED BY THE REPORTER AS A POSSIBLE SOURCE FOR THE PATIENT'S DETERIORATION IN STATUS. 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 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. THIS REPORT IS ASSOCIATED WITH MEDWATCH REPORT NUMBERS: 2015691-2013-19590 AND -19591.

    Description of Event or Problem · 1

    PER THE EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST REPORT, THE PATIENT PASSED AWAY 4 DAYS AFTER THE TRANSFEMORAL TAVR IMPLANT OF A SAPIEN VALVE. THE PHYSICIANS REPORTED THAT THE PATIENT WAS FOUND TO HAVE SEVERE AORTIC INSUFFICIENCY (AI) ON THE 2 DAYS POST TAVR ECHO AND POSSIBLE BOWEL EMBOLIZATION. THE AI INCREASED FROM NONE TO WIDE OPEN. CASE SUMMARY: POST TRANSFEMORAL DEPLOYMENT, THE 23MM SAPIEN VALVE WAS DEPLOYED TOO AORTIC (70:30) CAUSING MODERATE-SEVERE AI. A 2ND SECOND 23MM SAPIEN VALVE WAS DEPLOYED IN GOOD POSITION (50:50) WITH NO AI ON ECHO. AS REPORTED, THE 1ST VALVE MOVED A LITTLE AORTIC DURING DEPLOYMENT BECAUSE IT WAS DEPLOYED IN A SUBOPTIMAL VIEW. PERICARDIAL EFFUSION WAS NOTED ON ECHO, WHICH WAS DUE TO LV PERFORATION CLOSE TO THE APEX. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING THE NATIVE AORTIC VALVE WITH THE RETROFLEX3 DELIVERY SYSTEM; IT IS NOT YET CLEAR IF BAV WAS PERFORMED FIRST. THE PATIENT HAD A SMALL LEFT VENTRICLE AND THE RF3 DELIVERY SYSTEM WAS PERCEIVED TO PUSH THROUGH THE VENTRICLE WHEN THE VALVE WAS BEING POSITIONED IN THE ANNULUS. THE SURGEON PERFORMED A PERICARDIAL WINDOW, EVACUATING 500CC OF BLOOD. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TRANSPORTED TO ICU.

    Description of Event or Problem · 1

    PER THE EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST REPORT, THE PATIENT PASSED AWAY 4 DAYS AFTER THE TRANSFEMORAL TAVR IMPLANT OF A SAPIEN VALVE. THE PHYSICIANS REPORTED THAT THE PATIENT WAS FOUND TO HAVE SEVERE AORTIC INSUFFICIENCY (AI) ON THE 2 DAYS POST TAVR ECHO AND POSSIBLE BOWEL EMBOLIZATION. THE AI INCREASED FROM NONE TO WIDE OPEN. CASE SUMMARY: POST TRANSFEMORAL DEPLOYMENT, THE 23MM SAPIEN VALVE WAS DEPLOYED TOO AORTIC (70:30) CAUSING MODERATE-SEVERE AI. A 2ND SECOND 23MM SAPIEN VALVE WAS DEPLOYED IN GOOD POSITION (50:50) WITH NO AI ON ECHO. AS REPORTED, THE 1ST VALVE MOVED A LITTLE AORTIC DURING DEPLOYMENT BECAUSE IT WAS DEPLOYED IN A SUBOPTIMAL VIEW. PERICARDIAL EFFUSION WAS NOTED ON ECHO, WHICH WAS DUE TO LV PERFORATION CLOSE TO THE APEX. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING THE NATIVE AORTIC VALVE WITH THE RETROFLEX3 DELIVERY SYSTEM; IT IS NOT YET CLEAR IF BAV WAS PERFORMED FIRST. THE PATIENT HAD A SMALL LEFT VENTRICLE AND THE RF3 DELIVERY SYSTEM WAS PERCEIVED TO PUSH THROUGH THE VENTRICLE WHEN THE VALVE WAS BEING POSITIONED IN THE ANNULUS. THE SURGEON PERFORMED A PERICARDIAL WINDOW, EVACUATING 500CC OF BLOOD. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TRANSPORTED TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114497 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death