BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEAT SET

    MDR report key: 2904170 · Received January 9, 2013

    Report

    Report Number
    2015691-2013-19055
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL FOLLOW-UP INFORMATION: ACCORDING TO THE CS, THERE WAS NO DIFFICULTY WITH INSERTION OF THE SHEATH. THERE WAS NO MALFUNCTION OF THE SHEATH AND NOTHING ABNORMAL NOTICED WHILE INSPECTING THE DEVICE PRIOR TO USE. IT WAS ALSO INDICATED THAT ACCORDING TO THE PHYSICIAN PROCTOR, HE FELT THAT THE SURGEON TIED ONE SUTURE TOO SHALLOW AND ONE TOO DEEP IN A VENTRICLE THAT WAS FAIRLY FRIABLE. 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. 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, AS REPORTED, THE FRIABLE NATURE OF THE APEX TISSUE, IN COMBINATION WITH THE LOCATION OF THE SUTURES, CAUSED THE BLEEDING AT THE TIME OF SHEATH PLACEMENT. 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 CLINICAL SPECIALIST(CS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, AFTER THE EDWARDS SHEATH WAS PLACED, THE SURGEON PULLED THE SUTURES TIGHT, AND THE VENTRICLE PERFORATED OUTSIDE THE SUTURE RING. THE PATIENT WAS PUT ON BYPASS AND FIVE UNITS OF BLOOD WERE TRANSFUSED. AFTER SUCCESSFUL DEPLOYMENT OF THE SAPIEN VALVE,THE VENTRICLE WAS REPAIRED AND THE PATIENT TAKEN OFF BYPASS WITHOUT INCIDENT. THE PATIENT WAS ADMITTED TO THE CVICU AS PER PROTOCOL. THE PHYSICIAN COMMENTED THAT THE MUSCLE WAS VERY SOFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11043 ASCENDRA INTRODUCER SHEAT SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59310157

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention