BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEAT SET

    MDR report key: 2992741 · Received March 7, 2013

    Report

    Report Number
    2015691-2013-19470
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), CATHETER SITE BLEEDING WHICH MAY REQUIRE INTERVENTION AND CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. UPON REVIEW OF PRIOR EVENTS, THE MAJORITY OF APICAL BLEEDING COMPLICATIONS/VENTRICLE RUPTURES APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. IN THIS CASE, THE EVENT APPEARS TO BE RELATED TO PROCEDURAL FACTORS/ OPERATOR HANDLING, SPECIFICALLY DURING CLOSURE OF THE PURSE-STRINGS THE FIRST SUTURE BROKE, CAUSING THE APEX TO TEAR. THERE IS NO EVIDENCE THAT THE EVENT IS DIRECTLY RELATED TO THE EDWARDS SHEATH. POST PROCEDURE, THE TEAM DISCUSSED THE IMPORTANCE OF SUTURE PLACEMENT AND INTEGRITY OF THE APEX. 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. (B)(4). NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAPICAL TAVR PROCEDURE, AFTER REMOVAL OF THE SHEATH AND UPON CLOSURE OF THE PURSESTRINGS, THE APEX TORE AT THE SUTURE SITE, RESULTING IN SUBSTANTIAL BLEEDING. ADDITIONAL INFORMATION: THE FIRST SUTURE BROKE WHICH RESULTED IN THE BLEEDING. PER REPORT, THE APEX WAS NOT FRIABLE AND THE SUTURES WERE PLACED CORRECTLY. THE PRESSURE DROPPED INTO THE 70'S AND THE PATIENT WAS PUT ON BYPASS TO REPAIR THE APEX. THE PATIENT WAS WEANED OFF BYPASS BEFORE LEAVING THE ROOM AND RECOVERED IN THE SURGICAL UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97207 ASCENDRA INTRODUCER SHEAT SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention