BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 10344653 · Received July 30, 2020

    Report

    Report Number
    2015691-2020-12831
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 27, 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

    SECTION H10: SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 5 </NOE> EVENTS OF UNDETERMINED STROKE SERIOUS INJURY EVENTS FOR THE SAPIEN 3 FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 5 EVENTS OF UNDETERMINED STROKE FOR THE SAPIEN 3 VALVE IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 10.2. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4). PER THE INSTRUCTIONS FOR USE, PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INVASIVE CARDIAC PROCEDURE INCLUDING TRANSCATHETER HEART VALVE PROCEDURES. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY BY EDWARDS LIFESCIENCES, STROKE IS RECOGNIZED IN THE LITERATURE AS A WELL-KNOWN COMPLICATION IN A SMALL NUMBER OF PATIENTS UNDERGOING TAVR. RISK FACTORS CORRELATING WITH SEVERAL PATIENT CO-MORBIDITIES HAVE BEEN IDENTIFIED. ALTHOUGH IN MANY CASES THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, STROKES DURING TAVR ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA-PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING TAVR DEMONSTRATED THAT THE MAJORITY OF PROCEDURAL EMBOLIC EVENTS OCCURRED DURING BALLOON VALVULOPLASTY, MANIPULATION OF CATHETERS ACROSS THE AORTIC VALVE, AND VALVE IMPLANTATION. AN ANALYSIS IN PATIENTS UNDERGOING VALVE SURGERY REVEALED FOUR BASELINE CHARACTERISTICS AND TWO PROCEDURAL EVENTS THAT WERE ASSOCIATED WITH EARLY POST-PROCEDURE STROKE: FEMALE SEX, EF < 30%, DIABETES, AGE OLDER THAN 70 YEARS, BYPASS PROCEDURE TIME> 120 MIN, AND CALCIFICATION OF THE ASCENDING AORTA. PREDICTORS OF LATE STROKE HAVE INCLUDED FEMALE SEX, AGE OLDER THAN 75 YEARS, ATRIAL FIBRILLATION, AND A HISTORY OF OR CURRENT SMOKING. THERE WERE NO IMPORTANT DIFFERENCES IN THE FREQUENCY OF LATE STROKES BETWEEN TAVR AND AVR PATIENTS. AFTER TAVR, THERE APPEARS TO BE A MORE SIGNIFICANT PROPORTION OF EARLY STROKES OCCURRING < 24 H POST-PROCEDURE, BUT TAVR PATIENTS WITH MULTIPLE CO MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. IN THIS CASE, THE EVENT IS LISTED AS UNDETERMINED STROKE. IT IS NOT KNOWN IF THE MECHANISM OF THE STROKE IS IN QUESTION, OR IF THE STROKE ITSELF IS IN QUESTION. IT IS POSSIBLE THAT THE MECHANISM 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

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR (B)(6) 2020 DATA EXTRACT FOR AORTIC SERIOUS INJURY EVENTS FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 5 EVENTS OF UNDETERMINED STROKE IN THE AORTIC POSITION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE FOR (B)(6) 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 69-91. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES AND 3 MALES. (B)(6) 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q4 2019 (OCTOBER 1 ¿ DECEMBER 31).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810639 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other