BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9355394 · Received November 21, 2019

    Report

    Report Number
    2015691-2019-04314
    Event Type
    Death
    Date Received
    November 21, 2019
    Date of Event
    March 1, 2008
    Report Date
    October 31, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWELVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.  PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2019-04315. 2015691-2019-04316. 2015691-2019-04317. 2015691-2019-04318. 2015691-2019-04319. 2015691-2019-04320. 2015691-2019-04321. 2015691-2019-04322. 2015691-2019-04323. 2015691-2019-04324. 2015691-2019-04325.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWELVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM 01-MAR-2008 TO 31-OCT-2011. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-MAR-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. REFERENCE ARTICLE: DUBOIS, CHRISTOPHE, ET AL. "PROSPECTIVE EVALUATION OF CLINICAL OUTCOMES IN ALL-COMER HIGH-RISK PATIENTS WITH AORTIC VALVE STENOSIS UNDERGOING MEDICAL TREATMENT, TRANSCATHETER OR SURGICAL AORTIC VALVE IMPLANTATION FOLLOWING HEART TEAM ASSESSMENT." INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 17.3 (2013): 492-500. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  THE ARTICLE REPORTS FOUR TRANSFEMORAL PROCEDURES WERE COMPLICATED WITH CARDIAC TAMPONADE AND 2 OF THESE PATIENTS NEEDED SURGICAL REVISION AND DIED IN THE POSTOPERATIVE PERIOD. DETAILS OF THE EVENTS WERE NOT PROVIDED. THE CAUSE OF THE EVENTS IS UNKNOWN; HOWEVER, PROCEDURAL AND PATIENT FACTORS NOT PROVIDED COULD 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 LIFESCIENCES AFFILIATE IN BELGIUM, THROUGH THE REVIEW OF THE MEDICAL ARTICLE ¿PROSPECTIVE EVALUATION OF CLINICAL OUTCOMES IN ALL-COMER HIGH-RISK PATIENTS WITH AORTIC VALVE STENOSIS UNDERGOING MEDICAL TREATMENT, TRANSCATHETER OR SURGICAL AORTIC VALVE IMPLANTATION FOLLOWING HEART TEAM ASSESSMENT¿ REGARDING A GROUP OF PATIENTS WHO UNDERWENT TAVI BY TF OR TA APPROACH WITH AN EDWARDS SAPIEN VALVE OR EDWARDS SAPIEN-XT, THE FOLLOWING OUTCOMES WERE OBSERVED: FOUR TRANSFEMORAL PROCEDURES WERE COMPLICATED WITH CARDIAC TAMPONADE AND 2 OF THESE PATIENTS NEEDED SURGICAL REVISION AND DIED IN THE POSTOPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149027 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| R