BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 7656663 · Received July 2, 2018

    Report

    Report Number
    2015691-2018-02584
    Event Type
    Death
    Date Received
    July 2, 2018
    Date of Event
    April 1, 2015
    Report Date
    June 7, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    REF. RELATED MFGR. REPORT NUMBERS: 2015691-2018-02559, 2015691-2018-02560, 2015691-2018-02578, 2015691-2018-02579, 2015691-2018-02582, 2015691-2018-02586.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TREATED BETWEEN APRIL 2015 AND SEPTEMBER 2017. THE TYPE OF VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE PMA NUMBERS FOR THE SAPIEN XT (P130009) AND SAPIEN 3 (P140031) VALVES. THE DEPLOYMENT POSITION IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE CODES NPU (MITRAL) AND NPT (AORTIC). THE VALVES WERE NOT RETURNED TO EDWARDS LIFESCIENCES AS THEY REMAIN IMPLANTED IN THE PATIENT¿S. PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TVR PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY, WRITTEN BY EDWARDS LIFESCIENCES, STROKE IS RECOGNIZED IN THE LITERATURE AS A WELL-KNOWN COMPLICATION IN A SMALL NUMBER OF PATIENTS UNDERGOING TVR. 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 TVR ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA-PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING TVR DEMONSTRATED THAT THE MAJORITY OF PROCEDURAL EMBOLIC EVENTS OCCURRED DURING BALLOON VALVULOPLASTY, MANIPULATION OF CATHETERS ACROSS THE VALVE, AND VALVE IMPLANTATION. AN ANALYSIS IN PATIENTS UNDERGOING VALVE SURGERY REVEALED FOUR BASELINE CHARACTERISTICS AND TWO PROCEDURAL EVENTS THAT WERE ASSOCIATED WITH EARLY POSTPROCEDURE 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 TVR AND SVR PATIENTS. AFTER TVR, THERE APPEARS TO BE A MORE SIGNIFICANT PROPORTION OF EARLY STROKES OCCURRING < 24 H POST-PROCEDURE, BUT TVR PATIENTS WITH MULTIPLE CO MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THESE ADVERSE EVENTS. THE CAUSE OF EACH OF THE STROKES IS UNKNOWN, HOWEVER, MAY BE DUE TO PATIENT FACTORS (NOT PROVIDED) OR THE MECHANISMS DESCRIBED ABOVE. 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. BIBLIOGRAPHY: PRAZ, FABIEN, ET AL. "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION." THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY (2018).

    Description of Event or Problem · 1

    AS REPORTED THROUGH A JOURNAL ARTICLE TITLED, "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION" POST TVR PROCEDURE, (EXACT DATES UNKNOWN), 2 PATIENTS HAD A STROKE. ONE PATIENT HAD A NON-DISABLING STROKE WHILE IN THE HOSPITAL AND THE SECOND HAD A DISABLING STROKE BETWEEN DISCHARGE AND THE 30 DAY FOLLOW UP. THE PATIENT WITH THE DISABLING STROKE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497293 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O