BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120518 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20124
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. NEUROLOGICAL EVENTS, INCLUDING STROKE AND TIA, HAVE BEEN REVIEWED BY EDWARDS AND DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY. STROKE IS RECOGNIZED IN THE LITERATURE AS A WELL-KNOWN COMPLICATION IN A SMALL NUMBER OF PATIENTS UNDERGOING TAVR. RISK FACTORS CORRELATING WITH A NUMBER OF PATIENT CO-MORBIDITIES HAVE BEEN IDENTIFIED. ALTHOUGH IN MANY CASES THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, STROKES DURING TAVR ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA-PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING TAVR DEMONSTRATED THAT THE MAJORITY OF PROCEDURAL EMBOLIC EVENTS OCCURRED DURING BALLOON VALVULOPLASTY, MANIPULATION OF CATHETERS ACROSS THE AORTIC VALVE, AND VALVE IMPLANTATION. AN ANALYSIS IN PATIENTS UNDERGOING VALVE SURGERY REVEALED FOUR BASELINE CHARACTERISTICS AND TWO PROCEDURAL EVENTS THAT WERE ASSOCIATED WITH EARLY POST-PROCEDURE STROKE: FEMALE SEX, EF < 30%, DIABETES, AGE OLDER THAN 70 YEARS, BYPASS PROCEDURE TIME> 120 MIN, AND CALCIFICATION OF THE ASCENDING AORTA. PREDICTORS OF LATE STROKE HAVE INCLUDED FEMALE SEX, AGE OLDER THAN 75 YEARS, ATRIAL FIBRILLATION, AND A HISTORY OF OR CURRENT SMOKING. THERE WERE NO IMPORTANT DIFFERENCES IN THE FREQUENCY OF LATE STROKES BETWEEN TAVR AND AVR PATIENTS. AFTER TAVR, THERE APPEARS TO BE A MORE SIGNIFICANT PROPORTION OF EARLY STROKES OCCURRING < 24 H POST-PROCEDURE, BUT TAVR PATIENTS WITH MULTIPLE CO MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. IN THIS CASE, THE PATIENT SUFFERED A STROKE SEVERAL DAYS POST PROCEDURE. IN ADDITION TO THE PROCEDURE ITSELF, THE PATIENT WAS (B)(6) AND FEMALE WHICH MAY HAVE PUT HER AT HIGHER RISK FOR STROKE POST TAVR. 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.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH NEUROLOGICAL SYMPTOMS 4 OR 5 DAYS POST TAVR PROCEDURE. THERE WAS NO ISSUE WITH THE VALVE, IT WAS WORKING PROPERLY. THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT WITH A LOW BLOOD PRESSURE AND PULSE. WHEN SHE GOT TO THE UNIT SHE WAS UNRESPONSIVE WITH A BLOWN PUPIL. THE PATIENT LATER EXPIRED. THE PHYSICIAN BELIEVED THE PATIENT HAD A STROKE, THOUGH THEY WERE UNABLE TO CONFIRM IT WITHOUT AN AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221932 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death