BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 9240845 · Received October 25, 2019

    Report

    Report Number
    2015691-2019-03958
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    June 18, 2015
    Report Date
    October 3, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATES OF EVENTS ARE UNKNOWN, THEREFORE THE SAPIEN 3 APPROVAL DATE WAS ENTERED DURING THE PREVIOUS SUBMISSION.  H10:  PLEASE REFERENCE RELATED MANUFACTURER REPORT NUMBERS: 2015691-2018-02059, 2015691-2019-03890, 2015691-2019-03891, 2015691-2019-03893, 2015691-2019-03894, 2015691-2019-03895, 2015691-2019-03958, 2015691-2019-03985, 2015691-2019-03987, 2015691-2019-03988.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE VALVES WERE NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION, AS THEY REMAIN IMPLANTED IN THE PATIENTS. PER THE INSTRUCTIONS FOR USE (IFU), ACCESS SITE COMPLICATIONS AND CARDIOVASCULAR INJURY, INCLUDING PERFORATION OF THE VENTRICLE OR MYOCARDIUM, BLEEDING, OR VALVULAR STRUCTURES ARE POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TMVR PROCEDURE. A PROCEDURAL OR POST PROCEDURAL BLEED/ HEMORRHAGE WITHOUT AN OBVIOUS SOURCE OF BLEEDING IS A RARE BUT POTENTIALLY LIFE-THREATENING COMPLICATION OF CORONARY/CARDIAC INTERVENTIONAL PROCEDURES AND TENDS TO OCCUR MORE FREQUENTLY IN THE PRESENCE OF MORE AGGRESSIVE ANTICOAGULATION REGIMENS. POSSIBLE CAUSES INCLUDE INADVERTENT TRAUMA OR PERFORATION OF THE ANNULAR STRUCTURE OR VENTRICLES DURING THE PROCEDURE. THIS TYPE OF BLEEDING MAY NOT BE RECOGNIZED UNTIL THE POST PROCEDURAL PERIOD. IN THIS CASE, THE CAUSE OF THE POST PROCEDURAL BLEEDING FOR EACH OF THE CASES CANNOT BE DETERMINED. THE AUTHORS DID NOT SPECIFY TO WHICH OF THE DEVICES USED DURING THE TAVR PROCEDURE THESE EVENTS WERE ASSOCIATED, OR FROM WHERE THE BLEEDING OCCURRED. HOWEVER, THERE WAS NO ALLEGATION OR INDICATION OF 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. BIBLIOGRAPHY: LANZ, JONAS. A RANDOMIZED COMPARISON OF THE ACURATE NEO VERSUS THE SAPIEN 3 TRANSCATHETER HEART VALVE SYSTEMS IN PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS. ORAL PRESENTATION AT TCT ANNULAR MEETING; SEPTEMBER, 2019; SAN FRANCISCO, CA.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS AFFILIATE IN (B)(6), DURING A PRESENTATION AT TCT 2019 TITLED, ¿A RANDOMIZED COMPARISON OF THE ACURATE NEO VERSUS THE SAPIEN 3 TRANSCATHETER HEART VALVE SYSTEMS IN PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS" IT WAS REPORTED THAT POST DEPLOYMENT OF THE SAPIEN 3 VALVE, AT 30 DAYS, NINE PATIENTS HAD POST PROCEDURAL BLEEDING THAT REQUIRED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031304 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention