BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2963601 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19289
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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. THE CAUSE FOR THE REPORTED EVENT CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED; HOWEVER, IN THIS CASE, PER REPORT, THE PERCEIVED CAUSE OF THE CAI WAS THE PATIENT'S ANATOMY, PRIMARILY A TORTUOUS THORACIC AORTA AND A HEART THAT WAS VERY ROTATED. THE CAI WAS RESOLVED BY THE IMPLANTATION OF A SECOND SAPIEN VALVE IN THE SAME POSITION AS THE FIRST VALVE. 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 BY THE EDWARDS FIELD CLINICAL SPECIALIST, POST DEPLOYMENT OF A 26MM SAPIEN VALVE THERE WAS SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI). A SECOND SAPIEN VALVE WAS SUBSEQUENTLY IMPLANTED WITHIN THE FIRST, WHICH RESOLVED THE CAI. CASE SUMMARY: THE NATIVE AORTIC ANNULUS MEASURED 23.9-24MM ON TEE. THE NATIVE VALVE/LEAFLET CALCIFICATION WAS SEVERE AND BULKY. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED UNDER RAPID VENTRICULAR PACING (RVP). DUE TO EXTREME TORTUOSITY IN THE THORACIC AORTA, DIFFICULTY WAS ENCOUNTERED CROSSING THE NATIVE AORTIC ANNULUS WITH THE DELIVERY SYSTEM. PER REPORT, THERE WAS FAIR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM. THE 26MM SAPIEN WAS THEN DEPLOYED WHILE RESPIRATION WAS HELD AND RVP PERFORMED. THE VALVE WAS DEPLOYED 60:40 AORTIC. MODERATE CAI WAS INITIALLY NOTED ON TEE; HOWEVER; HEMODYNAMICALLY, THE PATIENT BECAME SOMEWHAT UNSTABLE WITH THE LV DIASTOLIC AND AO DIASTOLIC PRESSURE EQUALIZING AND THE PA PRESSURES INCREASING. THE ECHOCARDIOGRAPHER COULD NOT GET A GOOD SHORT AXIS VIEW TO CONFIRM THAT ALL THREE LEAFLETS WERE FUNCTIONAL, BUT ON TEE IT APPEARED THAT ALL THREE LEAFLETS WERE MOVING. GENTLE MANIPULATION OF THE SAPIEN LEAFLETS WAS ATTEMPTED WITH THE PIGTAIL CATHETER. THE CAI WAS THEN NOTED TO BE 3+ ON TEE AND THE PHYSICIAN DECIDED TO IMPLANT A SECOND 26MM SAPIEN VALVE. THE SECOND SAPIEN VALVE WAS IMPLANTED IN THE SAME 60:40 AORTIC POSITION WITHIN THE FIRST VALVE. THE ECHOCARDIOGRAPHER NOTED THAT THERE WAS NO LONGER ANY CAI AND THE PATIENT'S BLOOD PRESSURE IMPROVED. THE PATIENT RECOVERED AND REMAINED STABLE THROUGHOUT THE REMAINDER OF THE PROCEDURE. PER REPORT, THE PHYSICIAN FELT THAT THE FIRST SAPIEN VALVE WAS IMPLANTED IN THE EXACT POSITION THAT THE MEDICAL TEAM WANTED (60:40 AORTIC). THERE WAS NO CONCERN OF NATIVE LEAFLET OVERHANG. NOTHING UNUSUAL WAS NOTED ABOUT THE VALVE DURING DEVICE PREP. THE PERCEIVED CAUSE OF THE CAI WAS THE PATIENT'S ANATOMY, PRIMARILY A TORTUOUS THORACIC AORTA AND A HEART THAT WAS VERY ROTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68856 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention