BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120893 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20135
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    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. THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE IS NOT INDICATED FOR DELIVERY VIA A TRANSVENOUS TRANS-SEPTAL APPROACH; HOWEVER, HEART FAILURE AND LOW CARDIAC OUTPUT ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), THE USE OF ANESTHESIA, AORTIC VALVE REPLACEMENT AND THE TAVR PROCEDURE. DUE TO THE FACT THAT THIS IS AN OFF-LABEL USE OF THE DEVICE, THERE ARE NO SPECIFIC INSTRUCTIONS FOR THE DEPLOYMENT OF THE SAPIEN VALVE VIA A TRANSVENOUS TRANS-SEPTAL APPROACH. IN THIS CASE, PER THE IMPLANTING PHYSICIAN, THE LV FAILURE WAS DUE TO THE STUNNING OF THE LV DURING THE OFF LABEL PERFORATION OF THE LV SEPTUM. 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, DURING AN OFF LABEL TRANSVENOUS TRANS-SEPTAL TAVR PROCEDURE, THE 23MM SAPIEN VALVE WAS IMPLANTED IN A 60:40 AORTIC POSITION. THE PATIENT¿S BLOOD PRESSURE WAS 72/48 AND WAS SLOW TO RECOVER. POST DILATION WAS PERFORMED UNDER RAPID VENTRICULAR PACING (RVP). AFTER POST DILATION, THE LEFT VENTRICLE HAD MINIMAL FUNCTION WITH AN EJECTION FRACTION (EF) OF 5%, AND THE PATIENT¿S BLOOD PRESSURE DROPPED TO 42/20. SIX MINUTES OF CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AFTER WHICH THE PATIENT HAD A HEART RATE (HR) OF 157 BEATS PER MINUTE (BPM) AND A BLOOD PRESSURE OF 178/120. OVER THE NEXT FIVE MINUTES THE PATIENT¿S HR SLOWLY FELL AND RETURNED TO A HR OF 74 BPM. THE PATIENT¿S LV WAS ASSESSED ON TEE AND THE EF HAD IMPROVED TO 20%. THE SAPIEN VALVE APPEARED TO BE FUNCTIONING WELL WITH MINIMAL REGURGITATION. NO FURTHER INTERVENTION WAS PERFORMED, AND THE PATIENT WAS NOTED TO BE IN STABLE CONDITION POST PROCEDURE. THE PATIENT¿S BASELINE EJECTION FRACTION (EF) WAS 48%. THE PATIENT WAS NOT A CANDIDATE FOR A TRANSFEMORAL PROCEDURE (DUE TO A LESS THAN INDICATED VESSEL SIZE (6MM) IN COMBINATION WITH SEVERE CALCIFICATION AND TORTUOSITY) OR FOR A TRANSAPICAL PROCEDURE (DUE TO AN LV ANEURYSM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221759 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention