BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 13194171 · Received January 7, 2022

    Report

    Report Number
    2015691-2022-03274
    Event Type
    Injury
    Date Received
    January 7, 2022
    Report Date
    January 7, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. CITATION: GAMAL, AMR S., ET AL. 'OUTCOMES OF DIRECT FLOW MEDICAL VS SAPIEN 3 TRANSCATHETER AORTIC VALVE DEVICES.' JOURNAL OF CARDIOVASCULAR TRANSLATIONAL RESEARCH (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS SUCH AS TRANSIENT ISCHEMIC ATTACK (TIA) AND STROKE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE THV PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. ACCORDING TO THE 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 THV. RISK FACTORS CORRELATING WITH SEVERAL PATIENT CO-MORBIDITIES HAVE BEEN IDENTIFIED. ALTHOUGH IN MANY CASES THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, STROKES DURING THV ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA-PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING THV 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 (B)(6), 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 THV AND AVR PATIENTS. AFTER THV, THERE APPEARS TO BE A MORE SIGNIFICANT PROPORTION OF EARLY STROKES OCCURRING 24 H POST-PROCEDURE, BUT THV PATIENTS WITH MULTIPLE CO-MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. PER THE INSTRUCTIONS FOR USE (IFU), CVA IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE EXACT CAUSE OF THE CVA IS UNKNOWN AND NO PATIENT FACTORS WERE PROVIDED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2022-03271 AND 2015691-2022-03279.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, REVIEW OF THE MEDICAL ARTICLE: 'OUTCOMES OF DIRECT FLOW MEDICAL VS SAPIEN 3 TRANSCATHETER AORTIC VALVE DEVICES' WAS PERFORMED. THIS IS A SINGLE-CENTER EXPERIENCE IN WHICH WAS ENROLLED CONSECUTIVE PATIENTS WITH SEVERE SYMPTOMATIC AORTIC STENOSIS AND HIGH OR PROHIBITIVE SURGICAL RISK WHO UNDERWENT TAVI WITH SAPIEN 3 BETWEEN FEBRUARY 2014 AND AUGUST 2016. NINETY-NINE PATIENTS RECEIVED THE SAPIEN 3 VALVE. ONE PATIENT EXPERIENCED A CVA PRIOR TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517695 SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention