BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 14251335 · Received April 29, 2022

    Report

    Report Number
    2015691-2022-05467
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    January 1, 2014
    Report Date
    May 4, 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 TEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM JANUARY 2014 AND JUNE 2019. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-JANUARY 2014) WAS USED AS THE OCCURRENCE DATE. PATIENT MEDICAL RECORDS AND PROCEDURE OP NOTES (IMPLANT AND VALVE IN VALVE) WERE NOT PROVIDED FOR REVIEW. 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 THE VALVE IN VALVE IS NOT AVAILABLE AT THIS TIME. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE EVENT WAS RELATED TO A DEVICE MALFUNCTION. THE REASON FOR THE VALVE IN VALVE CANNOT BE CONFIRMED. IT IS POSSIBLE THAT PATIENT FACTORS AND CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THE VALVE IN VALVE. 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. ARTICLE CITATION: MICHEL JM, FRANGIEH AH, GIACOPPO D, ALVAREZ-COVARRUBIAS HA, PELLEGRINI C, RHEUDE T, DEUTSCH O, MAYR NP, RUMPF PM, STAHLI BE, KASTRATI A, SCHUNKERT H, XHEPA E, JONER M, KASEL AM. SAFETY AND EFFICACY OF MINIMALIST TRANSCATHETER AORTIC VALVE IMPLANTATION USING A NEW-GENERATION BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE IN BICUSPID AND TRICUSPID AORTIC VALVES. CLIN RES CARDIOL. 2021 DEC;110(12):1993-2006. DOI: 10.1007/S00392-021-01935-7. EPUB 2021 SEP 9. PMID: 34505192.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORT TO PROVIDE THAT THIS IS ONE OF TEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691- 2022- 05470, 2015691- 2022- 05471, 2015691- 2022- 05473, 2015691- 2022- 05474, 2015691- 2022- 05475, 2015691- 2022- 05476, 2015691- 2022- 05478, 2015691- 2022- 05479 AND 2022- 05481.

    Description of Event or Problem · 0

    AS REPORTED BY OUR AFFILIATES IN (B)(4), THROUGH THE REVIEW OF THE MEDICAL ARTICLE: "SAFETY AND EFFICACY OF MINIMALIST TRANSCATHETER AORTIC VALVE IMPLANTATION USING A NEW-GENERATION BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE IN BICUSPID AND TRICUSPID AORTIC VALVES", CORRESPONDING AUTHOR A. MARKUS KASEL FROM KLINIK FUR HERZ- UND KREISLAUFERKRANKUNGEN OF THE GERMAN HEART CENTER IN MUNICH. 743 PATIENTS WITH NATIVE AORTIC VALVE DISEASE TREATED AT THE KLINIK FUR HERZ- UND KREISLAUFERKRANKUNGEN OF THE GERMAN HEART CENTER IN MUNICH, GERMANY, BETWEEN JANUARY 2014 AND JUNE 2019, IN A SINGLE-STRATEGY STANDARDIZED MINIMALIST SETTING USING THE SAPIEN 3 THV VIA THE TRANSFEMORAL ROUTE WERE EVALUATED. THE FOLLOWING EVENTS WERE IDENTIFIED: MULTIPLE VALVES MARKED AS PROCEDURAL COMPLICATION: 4 PATIENTS (3 WITH TRICUSPID LEAFLET, 1 WITH BICUSPID LEAFLET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204486 UNKNOWN SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention