BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 2922580 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19142
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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), 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. ADDITIONALLY, ACCORDING TO LITERATURE REVIEW, THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. FURTHERMORE, 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 REPORTED APICAL TEAR CANNOT BE CONFIRMED; HOWEVER, THE NOTED FRIABLE CARDIAC TISSUE LIKELY CAUSED THE EVENT. 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), ONCE APICAL ACCESS WAS ACHIEVED, THE PATIENT DEVELOPED AN APICAL TEAR. THE PATIENT'S APEX WAS VERY FRAIL. THE PHYSICIAN HAD DIFFICULTY CONTROLLING THE TEAR AND THE PATIENT WAS IMMEDIATELY PLACED ON CARDIOPULMONARY BYPASS (CPB). THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITHOUT FURTHER INCIDENT AND THE SAPIEN VALVE WAS IMPLANTED WITH GOOD FINAL RESULT. FOLLOWING THE PROCEDURE, THE PATIENT WAS NOTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27406 EDWARDS ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention