BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9296821 · Received November 8, 2019

    Report

    Report Number
    2015691-2019-04156
    Event Type
    Death
    Date Received
    November 8, 2019
    Date of Event
    November 1, 2008
    Report Date
    October 15, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.  PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2019-04152, 2015691-2019-04153, 2015691-2019-0415, 2015691-2019-04155, 2015691-2019-04156.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.  THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM NOVEMBER 2008 TO PUBLISH DATE NOVEMBER 2012. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD ((B)(6) 2008) 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 VALVES ARE:  P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT¿ TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. REFERENCE ARTICLE: WILBRING, MANUEL, ET AL. "TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION VS CONVENTIONAL AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS WITH PREVIOUS CARDIAC SURGERY: A PROPENSITY-SCORE ANALYSIS." EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 44.1 (2013): 42-47. PER THE INSTRUCTIONS FOR USE (IFU), HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING VASCULAR AND APICAL ACCESS, USE OF ANGIOGRAPHY, BALLOON VALVULOPLASTY, USE OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE BIO-PROSTHESIS IMPLANTATION.   PATIENTS UNDERGOING THE TAVR PROCEDURE CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. PATIENT RISK FACTORS FOR HYPOTENSION INCLUDE LOW EF, CAD, CHF, ARTERIOSCLEROSIS, HYPOVOLEMIA, AND ANEMIA.  ADDITIONALLY, THESE PATIENTS ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING, TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE HYPOTENSION IS NOT UNCOMMON AND IS TREATED WITH STANDARD THERAPIES, INCLUDING VASOACTIVE DRUGS. IT IS ALSO NOT UNCOMMON TO INITIATE BRIEF CHEST COMPRESSIONS OR CARDIAC MASSAGE TO FACILITATE DISTRIBUTION OF THESE VASOACTIVE DRUGS. IN SOME CASES, THESE STANDARD MANEUVERS ARE NOT ADEQUATE, AND INITIATION OF CARDIOPULMONARY BYPASS (CPB), INSERTION OF IABP, AND/OR CONVERSION TO OPEN SURGERY IS REQUIRED.   PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. AS A PRECAUTION, THE THV TRAINING MANUALS INSTRUCT THE OPERATOR TO MINIMIZE THE NUMBER AND DURATION OF RAPID BURST PACING EPISODES, AND ALLOW SUFFICIENT HEMODYNAMIC RECOVERY BEFORE INITIATING ANOTHER EPISODE OF RAPID PACING.   IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  ACCORDING TO THE ARTICLE, ONE PATIENT DIED FROM INTRAOPERATIVE LOW CARDIAC OUTPUT. DETAILS OF THE EVENT WERE NOT PROVIDED. HOWEVER, THE MECHANISMS DESCRIBED ABOVE MAY HAVE CONTRIBUTED TO THE EVENT. 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

    AS REPORTED BY AN EDWARDS AFFILIATE IN (B)(6), THROUGH THE REVIEW OF THE MEDICAL ARTICLE ¿TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION VS CONVENTIONAL AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS WITH PREVIOUS CARDIAC SURGERY: A PROPENSITY-SCORE ANALYSIS¿ REGARDING A GROUP OF PATIENTS WHO UNDERWENT TAVI WITH AN EDWARDS SAPIEN VALVE BY TA APPROACH, THE FOLLOWING IN-HOSPITAL POST-OPERATIVE COMPLICATIONS WAS OBSERVED: ONE PATIENT DIED FROM INTRAOPERATIVE LOW CARDIAC OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090285 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L