BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2991300 · Received March 6, 2013

    Report

    Report Number
    2015691-2013-19448
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE EDWARDS LIFESCIENCES CLINICAL SPECIALIST: AT THE ONE MONTH FOLLOW UP VISIT THE PATIENT IS FEELING WELL AND IS AMBULATING ON HER OWN.

    Additional Manufacturer Narrative · 1

    PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU), THE CORRECT SIZING OF THE BIOPROSTHESIS IS ESSENTIAL TO HELP PREVENT PARAVALVULAR LEAK OF THE BIOPROSTHETIC VALVE. PER THE THV PHYSICIAN TRAINING CURRICULUM, WHEN THE NATIVE ANNULUS DIAMETER IS LARGER THAN 21.5MM, A 26 MM SAPIEN VALVE IS PREFERABLE TO MINIMIZE THE PARAVALVULAR LEAK. FOR THIS ANNULUS A 23MM SAPIEN VALVE SHOULD BE CONSIDERED ONLY IN SPECIAL SITUATIONS, (E.G. THE PRESENCE OF SEVERE ANNULUS CALCIFICATION, BULKY LEAFLET AND LOW CORONARY OSTIA, NARROW ROOT AND LOW CORONARY OSTIA, OR A NARROW SINOTUBULAR JUNCTION). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE WAS NO ALLEGATION OF A VALVE MALFUNCTION. IN THIS CASE, THE EXACT ROOT CAUSE OF THE REPORTED MODERATE TO SEVERE AI POST VALVE DEPLOYMENT CANNOT BE CONFIRMED; HOWEVER, THE EVENT APPEARS TO BE RELATED TO A COMBINATION OF VALVE SIZE SELECTION AND PATIENT FACTORS. AS PER THE REPORT, THE PERIPHERAL VESSELS OF THE PATIENT WERE NOT SUITABLE FOR THE SAFE USE OF A 26MM RETROFLEX3 SYSTEM. FOR THIS REASON A DECISION WAS MADE TO IMPLANT A 23MM SAPIEN VALVE, EVEN THOUGH THE PATIENT'S NATIVE AORTIC ANNULUS DIAMETER WAS GREATER THAN THE RECOMMENDED SIZE FOR THIS VALVE (WHICH IS 18-22MM). 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.

    Description of Event or Problem · 1

    PER THE EDWARDS LIFESCIENCES CLINICAL SPECIALIST REPORT, DURING A TRANSFEMORAL TAVR PROCEDURE, POST DEPLOYMENT OF A 23MM SAPIEN VALVE, 2-3+ AORTIC INSUFFICIENCY (AI) WAS NOTED WITH TEE AND ANGIOGRAM. THE PATIENT'S AORTIC ANNULUS DIAMETER MEASURED 23MM IN THE TEE PERFORMED DURING SCREENING. THE PHYSICIAN'S TEAM WAS AWARE THAT THE PATIENT'S ANNULUS WAS MORE SUITABLE FOR A 26MM SAPIEN VALVE BUT THE PATIENT DID NOT HAVE ADEQUATE VASCULAR ACCESS FOR TRANSFEMORAL DELIVERY OF A 26MM VALVE AND THE ATTENDING PHYSICIAN FELT THAT THE PATIENT HAD NO OTHER ALTERNATIVE. THE MINIMUM LUMINAL DIAMETER OF THE PATIENT'S PERIPHERAL VASCULATURE MEASURED 7.6MM WITH SEVERE TORTUOSITY AND MILD CALCIFICATION, WHICH IS NOT ADEQUATE FOR THE 26MM RETROFLEX3 SYSTEM. THE 23MM SAPIEN VALVE WAS POSITIONED ACROSS THE AORTIC ANNULUS WITHOUT ANY DIFFICULTY. THE VALVE WAS THEN DEPLOYED UNDER RAPID VENTRICULAR PACING (RVP). POST DEPLOYMENT THE TEE SHOWED THE VALVE IN 50/50 POSITION WITH MODERATE TO SEVERE AI. THE PATIENT'S PRESSURE RECOVERED ADEQUATELY TO 145/77-80 MMHG. IT WAS DECIDED TO POST DILATE AND THE SYSTEM WAS RE-ADVANCED AND AGAIN INFLATED UNDER RVP. WHEN THE SYSTEM WAS RETRACTED, THE PRESSURE DID NOT RECOVER. POST ANGIOGRAM SHOWED SEVERE AI WITH A SYSTOLIC PRESSURE OF 40/19MMHG. PRESSORS WERE GIVEN AND CHEST COMPRESSIONS WERE INITIATED FOR DRUG CIRCULATION. A SECOND 23MM SAPIEN VALVE WAS PREPPED AND DEPLOYED PROXIMAL TO THE 1ST VALVE WITHOUT ANY ISSUES. POST DEPLOYMENT TEE SHOWED MILD TO MODERATE AI. THE PATIENT'S PRESSURE RECOVERED AND THEY WERE EXTUBATED IN THE CATH LAB AND TRANSFERRED TO THE RECOVERY UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95374 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention