BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9483181 · Received December 17, 2019

    Report

    Report Number
    2015691-2019-04704
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    October 1, 2012
    Report Date
    November 26, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL TO SUBMIT RELATED MDRS AND REFERENCE ARTICLE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2019-04703 AND 2015691-2019-04706 HULMAN M, BENA M, ARTEMIOU P, GASPAROVIC I, HUDEC V, HASAKOVA J. TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE BALLOON EXPANDABLE AORTIC BIOPROSTHETIC VALVE IN HIGH RISK PATIENTS WITH SEVERE AORTIC STENOSIS: INTERMEDIATE-TERM RESULTS FROM THE REGISTER OF THE CLINIC OF CARDIAC SURGERY. BRATISL LEK LISTY. 2019;120(6):462-467. DOI: 10.4149/BLL_2019_074. PUBMED PMID: 31223028.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE, FOR THE 4 PATIENTS HAD A STROKE OR TIA. THE DATE OF THE EVENT(S) IS UNKNOWN. ACCORDING TO THE ARTICLE THE DATE RANGE FOR THIS EVENT(S) IS FROM OCTOBER 2012 TO DECEMBER 2016. FOR THIS REASON, THE FIRST DAY OF THE RANGE WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE ARE LISTED BELOW; THIS REPORT WILL REMAIN BLANK. P130009 - EDWARDS SAPIEN XT¿ TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE WITH COMMANDER DELIVERY SYSTEM. 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 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 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OF THE REPORTED STROKES/TIA POST PROCEDURE CANNOT BE DETERMINED, AS NO ADDITIONAL PATIENT OR PROCEDURAL FACTORS WERE PROVIDED BY THE AUTHORS. HOWEVER, IT MAY BE RELATED TO THE MECHANISM NOTED 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.

    Description of Event or Problem · 1

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE: "TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE BALLOON EXPANDABLE AORTIC BIOPROSTHETIC VALVE IN HIGH RISK PATIENTS WITH SEVERE AORTIC STENOSIS: INTERMEDIATE-TERM RESULTS FROM THE REGISTER OF THE CLINIC OF CARDIAC SURGERY", BY AUTHOR HULMAN M, MULTIPLE EVENTS WERE IDENTIFIED. THE PURPOSE OF THIS STUDY IS TO REPORT THE EXPERIENCE IN PERFORMING TRANSAPICAL (TA) TAVR WITH A BALLOON-EXPANDABLE VALVE ONLY BY CARDIAC SURGEONS, WITH ON SITE INTERVENTIONAL CARDIOLOGY SUPPORT. IN THE PERIOD FROM OCTOBER 2012 TO DECEMBER 2016 A TOTAL OF 97 PATIENTS WITH SEVERE AORTIC STENOSIS WERE TREATED WITH THE TRANSAPICAL TAVR PROCEDURE WITH THE EDWARDS SAPIEN XT VALVE IN 31 (32 %) PATIENTS AND THE EDWARDS SAPIEN S3 IN 66 (68 %) PATIENTS. THE FOLLOWING EVENTS WERE IDENTIFIED: 1 PATIENT HAD A BLEEDING NEEDING RE-EXPLORATION 4 PATIENTS HAD A STROKE OR TIA 5 PATIENTS NEEDED A PACEMAKER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272239 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other