BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 12454392 · Received September 10, 2021

    Report

    Report Number
    2015691-2021-05109
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    July 21, 2021
    Report Date
    October 19, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H10 STATEMENT. IN THIS CASE, THE EXACT VALVE MODEL NUMBERS ARE NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. THE DATES OF THE EVENTS ARE UNKNOWN. FOR THIS REASON, THE DATE OF THE CONFERENCE PRESENTATION WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE VALVES ARE NOT AVAILABLE FOR EVALUATION; HOWEVER, THERE WAS NO INDICATION OR ALLEGATION THAT A PRODUCT DEFICIENCY CONTRIBUTED TO THE EVENT. THE REASON FOR 5 PATIENTS UNDERGOING A MITRAL VALVE REPLACEMENT DURING THIS STUDY PERIOD IS UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE EVENTS WERE RELATED TO A DEVICE MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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

    Additional Manufacturer Narrative · 0

    CORRECTION TO H10 STATEMENT. THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-05108 AND 2015691-2021-05110. IN THIS CASE, THE EXACT VALVE MODEL NUMBERS ARE NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. THE DATES OF THE EVENTS ARE UNKNOWN. FOR THIS REASON, THE DATE OF THE CONFERENCE PRESENTATION WAS USED AS THE OCCURRENCE DATE. EXPLANT OF A VALVE MAY BE DUE TO VALVE DYSFUNCTION (SEVERE OR CLINICALLY SIGNIFICANT PVL, CENTRAL LEAK, SIGNIFICANT MALPOSITION, EARLY/LATE ENDOCARDITIS, THROMBOSIS OR DEGENERATION) AND/OR OTHER REASONS. THE EDWARDS SAPIEN, SAPIEN XT AND SAPIEN 3 TRANSCATHETER HEART VALVE ARE INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THESE THV IN A NATIVE MITRAL VALVE IS NOT INDICATED PER THE LABELING; THEREFORE THE DEVICE LABELING (IFUS AND TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THESE VALVES IN THIS SCENARIO. IN THIS CASE, THE VALVES ARE NOT AVAILABLE FOR EVALUATION; HOWEVER, THERE WAS NO INDICATION OR ALLEGATION THAT A PRODUCT DEFICIENCY CONTRIBUTED TO THE EVENT. THE REASON FOR 5 PATIENTS UNDERGOING A MITRAL VALVE REPLACEMENT DURING THIS STUDY PERIOD IS UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE EVENTS WERE RELATED TO A DEVICE MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE: P110021, EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009, EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031, EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. THE DATES OF THE EVENTS ARE UNKNOWN. FOR THIS REASON, THE DATE OF THE CONFERENCE PRESENTATION WAS USED AS THE OCCURRENCE DATE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITH NO RESPONSE. AT THE TIME OF THIS REPORT, THE INFORMATION AVAILABLE DOES NOT REASONABLY SUGGEST THERE WAS A MALFUNCTION OF THE EDWARDS DEVICE OR THAT THE USE OR MISS-USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. TO DATE, THE PATIENT MEDICAL RECORDS AND PROCEDURE OP NOTES REQUESTED HAVE NOT BEEN RECEIVED FOR REVIEW. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IN THIS CASE, THE VALVE IS NOT AVAILABLE FOR EVALUATION; HOWEVER, THERE WAS NO INDICATION OR ALLEGATION THAT A PRODUCT DEFICIENCY CONTRIBUTED TO THE EVENT. THE REASON FOR EXPLANTING THE VALVE APPROXIMATELY 1 YEAR POST TAVR IS NOT AVAILABLE AT THIS TIME. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE EVENT WAS RELATED TO A DEVICE MALFUNCTION. 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

    AS REPORTED AT THE 'TVT: THE STRUCTURAL HEART SUMMIT 2021', DURING THE PRESENTATION 'OPEN TRANSATRIAL SAPIEN IN MAC REVIEW', A SINGLE CENTER STUDY WAS PERFORMED WITH 78 PATIENTS WHO UNDERWENT TRANSATRIAL TMVR WITH 5 SAPIEN/SAPIEN XT VALVES AND 73 SAPIEN 3 VALVES. OF THOSE 78 PATIENTS, 5 PATIENTS UNDERWENT A MITRAL VALVE REPLACEMENT DURING THIS STUDY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351693 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention