BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEAT SET

    MDR report key: 3033521 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19724
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE INCLUDE CATHETER SITE BLEEDING WHICH MAY REQUIRE INTERVENTION AND CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES. 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. ACCORDING TO LITERATURE REVIEW, THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. IN ADDITION, THE LITERATURE ALSO REPORTS THAT FRIABLE TISSUE MAY PREDISPOSE THIS PATIENT POPULATION TO THE DEVELOPMENT OF APICAL ACCESS SITE COMPLICATIONS. IN THIS CASE, THE CAUSE OF THE VENTRICLE RUPTURE CANNOT BE CONFIRMED; HOWEVER IT IS POSSIBLE THAT THE ADVANCED AGE OF THE PATIENT COULD HAVE INCREASED THE CHANCE FOR FRIABLE TISSUE AT THE APEX, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED VENTRICLE RUPTURE. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING CLOSURE AFTER TRANSAPICAL TAVR PROCEDURE THERE WAS BLEEDING FROM THE MYOCARDIUM.A MINI-THORACOTOMY WAS PERFORMED ON THE PATIENT'S LEFT SIDE, PURSE STRING SUTURES WERE PUT IN PLACE, AND TRANSAPICAL ACCESS WAS OBTAINED. THE HEART POSITION WAS DIFFICULT AND RIB LOCATION INTERFERED WITH ACCESS. A 26F SHEATH WAS PLACED IN THE LEFT VENTRICLE (LV). POST BAV AND DEPLOYMENT OF THE SAPIEN VALVE, THE DELIVERY SYSTEM WAS REMOVED AND RAPID PACING PERFORMED FOR SHEATH REMOVAL. THE PHYSICIANS REMOVED THE SHEATH AND USED THE PREVIOUSLY PLACED PURSE STRING SUTURES TO CLOSE THE LEFT VENTRICLE. DURING THE CLOSURE, EXCESSIVE BLEEDING WAS NOTICED DUE TO A TEAR IN THE MYOCARDIUM. IT WAS DECIDED TO PUT THE PATIENT ON-PUMP SO THE CARDIAC SURGEONS COULD REPAIR THE TEAR IN THE MYOCARDIUM. THE PATIENT REMAINED STABLE THROUGHOUT PROCEDURE AND THE REPAIR WAS COMPLETED. POST CLOSURE, THE PATIENT'S VITAL SIGNS WERE STABLE. HE WAS REMOVED FROM BYPASS AND EXTUBATED. THE PATIENT WAS TRANSPORTED TO CARDIAC CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136639 ASCENDRA INTRODUCER SHEAT SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59372075

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention