BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 14187898 · Received April 22, 2022

    Report

    Report Number
    2015691-2022-05339
    Event Type
    Death
    Date Received
    April 22, 2022
    Date of Event
    May 1, 2014
    Report Date
    May 12, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF EIGHT MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATE OF THE EVENTS IS UNKNOWN. ACCORDING TO THE ARTICLE ALL IMPLANTS WERE COMPLETED BETWEEN MAY 2014 TO MAY 2019. FOR THIS REASON, THE FIRST DAY OF THE RANGE WAS USED AS THE OCCURRENCE DATE. INVESTIGATION IS ONGOING. REFERENCE ARTICLE: DRITAN USEINI, MD, MARKUS SCHLOMICHER, MD, ASSEM AWEIMER, PETER HALDENWANG, MD PHD, JUSTUS STRAUCH, MD PHD, AND POLYKARPOS C. PATSALIS, MD. ''LONG-TERM OUTCOMES AFTER TRANSFEMORAL-TRANSCATHETER AORTIC VALVE IMPLANTATION IN VERY OLD PATIENTS USING THE BALLOON-EXPANDABLE BIOPROSTHESIS''. GERONTOLOGY & GERIATRIC MEDICINE (2022).

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2022-05334, 2015691-2022-05340, 2015691-2022-05342, 2015691-2022-05345, 2015691-2022-05346, 2015691-2022-05347, 2015691-2022-05349. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES, AND HEMATOMA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL THV PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA, OR ANNULAR RUPTURE DURING THE THV PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION, AND NARROW CALCIFIED STJ. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE, AND PROCEDURAL SUCCESS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PATIENT AND OR PROCEDURAL FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, 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 · 0

    AS REPORTED FROM OUR AFFILIATES IN (B)(4), PER ARTICLE, ''LONG-TERM OUTCOMES AFTER TRANSFEMORAL-TRANSCATHETER AORTIC VALVE IMPLANTATION IN VERY OLD PATIENTS USING THE BALLOON-EXPANDABLE BIOPROSTHESIS'', SINGLE-CENTER RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE AGE-RELATED EARLY AND LONG-TERM CLINICAL OUTCOMES AFTER TF-TAVI USING THE EDWARDS SAPIEN 3 VALVE. DATA FROM 103 CONSECUTIVE PATIENTS WITH SYMPTOMATIC AORTIC VALVE STENOSIS UNDERGOING TF-TAVI BETWEEN MAY 2014 AND MAY 2019 WERE ANALYZED. THE FOLLOWING EVENTS WERE IDENTIFIED: THERE WAS ONE INTRA-OPERATIVE DEATH DUE TO ANNULUS RUPTURE DESPITE SUBSEQUENTLY RESCUE ATTEMPT VIA EMERGENCY SURGICAL AORTIC VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183676 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R