BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS ESHEATH INTRODUCER SET

    MDR report key: 10857325 · Received November 17, 2020

    Report

    Report Number
    2015691-2020-14459
    Event Type
    Death
    Date Received
    November 17, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION H10:  EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES (B)(4) EVENTS OF BLEEDING AT ACCESS SITE FOR THE SAPIEN 3 IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS ESHEATH INTRODUCER SET IS 00690103193985. THE INSTRUCTIONS FOR USE (IFU) LIST HEMORRHAGE REQUIRING TRANSFUSION OR INTERVENTION AS A POTENTIAL RISK ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING POTENTIAL ACCESS COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION. THE MAJORITY OF TRANSFEMORAL ACCESS RELATED BLEEDING COMPLICATIONS ARE RELATED TO DISEASED ILEO-FEMORAL VESSELS AND/OR PROCEDURAL TECHNIQUE DURING THE INSERTION OR REMOVAL OF THE SHEATH AND/OR DILATORS. THERE ARE CASES WHERE THE BLEEDING IS SIGNIFICANT AND MORE COMPLEX INTERVENTION OR TRANSFUSION IS REQUIRED TO TREAT/PREVENT A PERMANENT INJURY FROM OCCURRING. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL/ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE VALVE CAN BE DELIVERED TRANSFEMORALLY. IN THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE; HOWEVER, A TRANSFUSION OF (B)(4) UNITS OR MORE OF BLOOD WAS REPORTED IN THE REGISTRY.  BY VARC DEFINITION, THE MEET CRITERIA FOR MAJOR VASCULAR COMPLATION; THEREFORE, THE EVENT IS BEING REPORTED.  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 AT THIS TIME.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 3 </NOE> DEATH EVENTS OF  BLEEDING AT ACCESS SITE FOR THE SAPIEN 3 FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 3 EVENTS OF AORTIC DISSECTION FOR THE SAPIEN 3 IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS ESHEATH INTRODUCER SET ARE (B)(4). THE INSTRUCTIONS FOR USE (IFU) LIST HEMORRHAGE REQUIRING TRANSFUSION OR INTERVENTION AS A POTENTIAL RISK ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING POTENTIAL ACCESS COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION. THE MAJORITY OF TRANSFEMORAL ACCESS RELATED BLEEDING COMPLICATIONS ARE RELATED TO DISEASED ILEO-FEMORAL VESSELS AND/OR PROCEDURAL TECHNIQUE DURING THE INSERTION OR REMOVAL OF THE SHEATH AND/OR DILATORS. THERE ARE CASES WHERE THE BLEEDING IS SIGNIFICANT AND MORE COMPLEX INTERVENTION OR TRANSFUSION IS REQUIRED TO TREAT/PREVENT A PERMANENT INJURY FROM OCCURRING. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL/ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE VALVE CAN BE DELIVERED TRANSFEMORALLY. IN THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE; HOWEVER, A TRANSFUSION OF 2 UNITS OR MORE OF BLOOD WAS REPORTED IN THE REGISTRY.  BY VARC DEFINITION, THE MEET CRITERIA FOR MAJOR VASCULAR COMPLATION; THEREFORE, THE EVENT IS BEING REPORTED.  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 AT THIS TIME.

    Description of Event or Problem · 1

    THV/TVT REGISTRY ALTERNATIVE SUMMARY REPORTING (ASR) ADVERSE EVENT SUBMISSION FOR AUGUST 2020 DATA EXTRACT FOR AORTIC DEATHS FOR THE SAPIEN 3. AUGUST 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q1 2020 (JANUARY 1 ¿ MARCH 31, 2020). THIS REPORT SUMMARIZES 3 DEATH EVENTS OF BLEEDING AT ACCESS SITE FOR THE SAPIEN 3 FOR AUGUST 2020. THE AGE RANGE FOR THESE EVENTS ARE FROM 77 TO 80. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 1 MALE AND 2 FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321390 EDWARDS ESHEATH INTRODUCER SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 914ESA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death