BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8404676 · Received March 8, 2019

    Report

    Report Number
    2015691-2019-00799
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    February 15, 2012
    Report Date
    February 14, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE MFG. REPORT NO. 2015691-2019-00788 AND 2015691-2019-00800.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P100041, P130009, AND P140031. PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED AND WRITTEN BY EDWARDS LIFESCIENCES 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 CAUSE OF THE STROKE MAY BE RELATED TO THE MECHANISM DESCRIBED ABOVE. OTHER POTENTIAL CONTRIBUTING FACTORS WERE NOT PROVIDED IN THE ARTICLE. THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. 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: MOHAMMED A. AL-HIJJI, M. C. (2019). LEFT VENTRICULAR REMODELING AND FUNCTION AFTER TRANSAPICAL VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT. CATHETERIZATION, CARDIOVASCULAR INTERVENTION 1-7.

    Description of Event or Problem · 1

    A SINGLE-CENTER RETROSPECTIVE STUDY OF ALL TAVR PERFORMED FROM FEBRUARY 2012 TO JUNE 2016 WAS PUBLISHED IN THE JOURNAL ARTICLE ¿LEFT VENTRICULAR REMODELING AND FUNCTION AFTER TRANSAPICAL VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT". THREE HUNDRED AND FIFTY-NINE PATIENTS UNDERWENT BALLOON-EXPANDABLE TAVR USING SAPIEN VALVES WERE INCLUDED. THESE CASES WERE BOTH TRANSAPICAL AND TRANSFEMORAL. ONE HUNDRED AND FIFTEEN PATIENTS WHO UNDERWENT TA TAVR (TA GROUP) WERE COMPARED TO 115 PROPENSITY MATCHED PATIENTS WHO UNDERGONE TF TAVR (TF GROUP). THIS REPORT IS FOR 1 PATIENT WHO EXPERIENCED A STROKE (TA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198584 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other