BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS ASCENDRA INTRODUCER SHEAT SET

    MDR report key: 3211223 · Received July 8, 2013

    Report

    Report Number
    2015691-2013-20557
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), ACCESS SITE COMPLICATIONS/CARDIOVASCULAR INJURY, INCLUDING PERFORATION OF THE VENTRICLE OR MYOCARDIUM, BLEEDING, AND INJURY AT THE SITE OF VENTRICULAR ACCESS THAT MAY REQUIRE REPAIR ARE POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TAVR PROCEDURE. PER LITERATURE REVIEW, RISK FACTORS FOR APICAL LACERATION AND BLEEDING INCLUDE FRIABLE TISSUE, FATTY APEX, CHRONIC STEROID USE, DILATED LV WITH THINNED WALLS, AND HYPERTENSION DURING REMOVAL OF THE SHEATH. WHILE PATIENT CHARACTERISTICS ARE IMPORTANT, ACHIEVING GOOD HEMOSTATIC CONTROL OF THE LV APEX IS ONE OF THE MOST CRITICAL STEPS IN ENSURING THE SUCCESS OF THE TRANSAPICAL PROCEDURE, PARTICULARLY IN THE ELDERLY WITH FRIABLE TISSUE. ADDITIONAL LITERATURE REVIEW CONFIRMS THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. THIS INFORMATION CORRELATES WITH REVIEW OF COMPLAINT HISTORY, REVEALING THAT THE MAJORITY OF APICAL BLEEDING COMPLICATIONS APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. THE THV TRAINING MANUALS NOTE THAT THAT REMOVAL OF THE SHEATH AND ATTEMPTED CLOSURE OF THE APICAL INCISION MAY BE ASSOCIATED WITH BLOOD LOSS. RAPID BURST PACING CAN BE USED TO LOWER THE SYSTEMIC BLOOD PRESSURE DURING SHEATH REMOVAL AND APICAL CLOSURE. THE THV TRAINING MANUALS ALSO RECOMMEND THE PHYSICIAN CONSIDER PERFORMING THE PROCEDURE UNDER FULL CPB SUPPORT FOR CERTAIN PATIENTS, INCLUDING THOSE WITH CARDIOGENIC SHOCK (CARDIAC INDEX < 2 L/MIN PER SQUARE METER) DESPITE VOLUME CHALLENGE AND INOTROPIC SUPPORT, PROFOUND LV, RV, OR BIVENTRICULAR DYSFUNCTION, AND NOTABLY FRIABLE APEX. IN THIS CASE, THE CAUSE OF THE LV TEAR AND SUBSEQUENT BLEEDING WAS INDICATED AS A FRIABLE, FATTY LV. IN ADDITION, THIS PATIENT WAS ELDERLY ((B)(6)), PUTTING HIM AT HIGHER RISK FOR THIS COMPLICATION. 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 PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), AFTER A FAILED ATTEMPT AT TRANSFEMORAL ACCESS, THE PATIENT WAS CONVERTED TO A TRANSAPICAL APPROACH FOR A TAVR PROCEDURE. THE LV WAS EXPOSED IN THE USUAL STERILE FASHION AND IT WAS NOTED THAT THE VENTRICLE WAS VERY FATTY IN APPEARANCE. POST PROCEDURE, WHILE ATTEMPTING TO CLOSE THE LV APEX IN THE USUAL SURGICAL FASHION, THE SUTURES PULLED THROUGH THE MUSCLE AND BLEEDING BEGAN. THE PATIENT WAS IMMEDIATELY PUT ON BYPASS SUPPORT SUCCESSFULLY. MULTIPLE ATTEMPTS WERE MADE TO CLOSE THE LV APEX INCLUDING: ATTEMPTING AMPLATZER SEPTAL OCCUDERS, BIOGLUE, SUPERGLUE, SUTURING A HEMISHIELD GRAFT AND SUPERGLUE. EVERY ATTEMPT WAS UNSUCCESSFUL AND EVERY EFFORT THAT COULD BE THOUGHT OF WAS ATTEMPTED TO CLOSE THE LV APEX AND STOP THE BLEEDING. EVENTUALLY THE PATIENT WAS PRONOUNCED DUE TO MAJOR BLEEDING. THIS PATIENT DID NOT HAVE A HISTORY OF STEROID USE OR ANY OTHER HISTORY THAT WOULD SPECIFICALLY EXPLAIN THE FATTY HEART OTHER THAN AGE. THE CAUSE OF THE TEAR AND SUBSEQUENT BLEEDING WAS INDICATED AS A FRIABLE, FATTY LV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311091 EDWARDS ASCENDRA INTRODUCER SHEAT SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death