BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 13837625 · Received March 21, 2022

    Report

    Report Number
    2015691-2022-04529
    Event Type
    Death
    Date Received
    March 21, 2022
    Report Date
    April 25, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER ARTICLE - "ACUTE TYPE A AORTIC DISSECTION AFTER TAVR IN AN OCTOGENARIAN WITH ASCENDING AORTA ANEURYSM". AUTHORS: HELEN HASHEMI, MD,A, SAHIL KHERA, MD, MPH,A, MALCOLM ANASTASIUS, MBBS, PHD,A ISMAIL EL-HAMAMSY, MD, PHD,B, GILBERT H.L. TANG, MD, MSC, MBA,B, SAMIN K. SHARMA, MD,A ANNAPOORNA KINI, MD,A STAMATIOS LERAKIS, MD, PHDA. 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. PER THE INSTRUCTIONS FOR USE (IFU), AORTIC DISSECTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THAT THE EXACT CAUSE OF THE VESSEL DISSECTION CANNOT BE CONFIRMED, INVESTIGATION RESULTS SUGGEST THAT PROCEDURAL FACTORS (DEVICE MANIPULATION) AND/OR POSSIBLE CALCIFICATION OF THE ACCESS VESSEL THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE PATIENT EXPIRED 3 DAYS POST THE CARDIOVASCULAR INJURY DUE TO AORTIC DISSECTION-RELATED COMPLICATIONS. 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. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 0

    UPDATE AND CORRECTION TO G2 FOUND DURING ADMINISTRATIVE REVIEW.

    Description of Event or Problem · 0

    AS REPORTED THROUGH A LITERATURE ARTICLE, POST IMPLANTATION OF A 23MM SAPIEN 3 ULTRA VALVE VIA TF APPROACH, AN ACUTE TYPE A AORTIC DISSECTION WAS NOTED FROM THE RIGHT SINUS TO THE ABDOMINAL AORTA. THE PATIENT WAS CONSERVATIVELY MANAGED AND EXPIRED DUE TO AORTIC DISSECTION-RELATED COMPLICATIONS 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531053 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX23A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Other| D