BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 20318224 · Received September 27, 2024

    Report

    Report Number
    2015691-2024-07432
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    October 13, 2021
    Report Date
    October 30, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR ADDITIONAL INFORMATION BASED ON ADMINISTRATIVE REVIEW. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: E1 TELEPHONE NUMBER AND ADDITIONAL CODE ADDED TO H6 HEALTH EFFECT CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    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 OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND THE USE OF THE EDWARDS TRANSCATHETER HEART VALVE (THV) DEVICES. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EW, 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 MOST 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 SIGNIFICANT DIFFERENCES IN THE FREQUENCY OF LATE STROKES BETWEEN THV AND AVR PATIENTS. AFTER THV, THERE APPEARS TO BE A MORE CONSIDERABLE 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE OF THE STROKE IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE . 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED FROM FRANCE VIA BENCHMARK STUDY, A 26MM SAPIEN 3 VALVE WAS IMPLANTED IN THE AORTIC POSITION BY TRANSFEMORAL APPROACH. ON POST OPERATIVE DAY 18, THE PATIENT EXPERIENCED A SHORT EPISODE OF BLINDNESS EVOKING A RETINAL TRANSIENT ISCHEMIC ATTACK. NO ACTIONS WERE TAKEN, AND OUTCOME OF THE EVENT WAS LISTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610778 SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other