BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 18841820 · Received March 5, 2024

    Report

    Report Number
    2015691-2024-01609
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 1, 2020
    Report Date
    March 8, 2024
    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

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR REFERENCE OF MFG. REPORT NUMBERS RELATED TO THIS COMPLAINT. THIS REPORT IS 1 OF 4 BEING SUBMITTED FOR THIS COMPLAINT. REFERENCE MFG. REPORT NO. 2015691-2024-01906, 2015691-2024-01613 AND 2015691-2024-01615.

    Additional Manufacturer Narrative · 0

    BIBLIOGRAPHY: CHAVARRIA, JORGE, ET AL. 'BESPOKE VALVE SIZING AVOIDS ANNULAR RUPTURE IN PATIENTS TREATED WITH A BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE.' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 100.5 (2022): 823-831. PER ARTICLE, THE VALVE REMAINS IMPLANTED IN THE PATIENT. 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 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. OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED. HOWEVER, THE REPORTED STROKE WITHIN 30 DAYS OF THE TAVR PROCEDURE MAY BE DUE 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

    A SINGLE-CENTER STUDY REPORTED THROUGH A EUROPEAN ARTICLE, 'BESPOKE VALVE SIZING AVOIDS ANNULAR RUPTURE IN PATIENTS TREATED WITH A BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE. THE STUDY WAS BETWEEN (B)(6) 2020 TO (B)(6) 2022 DURING WHICH ALL PATIENTS UNDERGOING TAVR AT OUR CENTER WERE TREATED WITH A SAPIEN 3 OR A SAPIEN 3 ULTRA VALVE. ALL PATIENTS UNDERWENT PRE-TAVR COMPUTED TOMOGRAPHY (CT) EVALUATION INCLUDING ANNULAR AND LVOT DIMENSIONS AND MEASUREMENT OF ANNULAR AND LVOT CALCIFICATION. THIS COMPLAINT IS FOR FIVE PATIENTS WITH AN UNKNOWN EDWARDS SAPIEN 3 VALVE IMPLANTED IN THE AORTIC POSITION PRESENTED WITH DISABLING STROKE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITHIN 30 DAYS AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583618 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other