BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS ASCENDRA+ INTRODUCER SHEATH

    MDR report key: 4860782 · Received June 22, 2015

    Report

    Report Number
    2015691-2015-01481
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: KNOWN INHERENT RISK OF PROCEDURE. THE ASC+ SHEATH WAS RETURNED TO EDWARDS FOR EVALUATION. DURING VISUAL INSPECTION, A SMALL TEAR IN THE CROSS SLIT VALVE WAS OBSERVED FROM THE TOP OF THE HOUSING. FOLLOWING FUNCTIONAL TESTING, THE SHEATH HOUSING WAS DISASSEMBLED. NO ADDITIONAL ABNORMALITIES WERE OBSERVED. NO ABNORMALITIES WERE OBSERVED WITH THE DUCKBILL AND DISC VALVE. FUNCTIONAL TESTING WAS PERFORMED WITH A 0.035¿ GUIDEWIRE INSERTED INTO THE SHEATH. DURING THE HEMOSTASIS TEST, THE DEVICE LEAKED AT A RATE ABOVE THE MAXIMUM RATE ALLOWED. DIMENSIONAL ANALYSIS WAS PERFORMED FOLLOWING FUNCTIONAL TESTING. THE SHEATH HOUSING WAS DISASSEMBLED AND THE OUTER DIAMETER (OD) OF THE DISC, CROSS SLIT AND DUCKBILL VALVES WAS MEASURED. THE OD OF ALL THREE VALVES MET SPECIFICATIONS. ALL SHEATHS UNDERGO MULTIPLE 100% INSPECTIONS DURING MANUFACTURING. THESE INSPECTIONS MAKE IT UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE OF THE SHEATH CAUSED THE REPORTED LEAKAGE. THE DEVICE HISTORY RECORD (DHR) RECORDS REVIEW DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE COMPLAINT OF LEAKAGE FROM THE ASC+ SHEATH HOUSING WAS CONFIRMED THROUGH HEMOSTASIS TESTING WITH A GUIDEWIRE INSERTED. A DAMAGED CROSS SLIT VALVE WAS OBSERVED ON THE RETURNED DEVICE. NO OTHER ABNORMALITIES WERE OBSERVED. THE PATTERN OF THE TEAR INDICATED THAT IT IS THE RESULT OF INTERACTION WITH A ROUGH SURFACE (SUCH AS AN INSERTED DEVICE) RATHER THAN A MATERIAL ISSUE. THE COMPLAINT WAS CONFIRMED, BUT NO MANUFACTURING NON-CONFORMITIES WERE FOUND IN THE RETURNED SAMPLE. NO LABELING OR IFU INADEQUACIES HAVE BEEN IDENTIFIED AND REVIEW OF COMPLAINT HISTORIES DID NOT REVEAL THAT OCCURRENCE RATE EXCEEDS CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR JAPAN AFFILIATE, DURING THE TRANSAPICAL TAVR PROCEDURE, BLEEDING FROM A HEMOSTASIS VALVE OF AN ASCENDRA+ (ASC+) SHEATH WAS OBSERVED. NO ISSUES WITH THE HEMOSTASIS VALVE FUNCTION WERE OBSERVED DURING INSERTION OF THE ASC+ SHEATH INTO THE PATIENT. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. FOLLOWING BAV, AS THE BALLOON CATHETER WAS WITHDRAWN, BLEEDING FROM THE HEMOSTASIS VALVE OF THE ASC+ SHEATH WAS OBSERVED. AN ATTEMPT WAS MADE TO CENTER THE GUIDEWIRE WITHIN THE SHEATH, BUT THE BLEEDING DID NOT STOP. A SMALL SHEATH WAS INSERTED INTO THE ASC+ SHEATH TO STOP THE BLEEDING. A 23MM SAPIEN XT VALVE WAS IMMEDIATELY IMPLANTED. FOLLOWING REMOVAL OF ALL DEVICES, NO ISSUES WITH THE HEMOSTASIS VALVE FUNCTION WERE OBSERVED. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION.

    Description of Event or Problem · 1

    AS REPORTED BY OUR (B)(4) AFFILIATE, DURING THE TRANSFEMORAL TAVR PROCEDURE, BLEEDING FROM A HEMOSTASIS VALVE OF AN ASCENDRA+ (ASC+) SHEATH WAS OBSERVED. NO ISSUES WITH THE HEMOSTASIS VALVE FUNCTION WERE OBSERVED DURING INSERTION OF THE ASC+ SHEATH INTO THE PATIENT. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. FOLLOWING BAV, AS THE BALLOON CATHETER WAS WITHDRAWN, MASSIVE BLEEDING FROM THE HEMOSTASIS VALVE OF THE ASC+ SHEATH WAS OBSERVED. AN ATTEMPT WAS MADE TO CENTER THE GUIDEWIRE, BUT THE BLEEDING DID NOT STOP. A SMALL SHEATH WAS INSERTED INTO THE ASC+ SHEATH TO STOP THE BLEEDING. A 23MM SAPIEN XT VALVE WAS IMMEDIATELY IMPLANTED. FOLLOWING REMOVAL OF ALL DEVICES, NO ISSUES WITH THE HEMOSTASIS VALVE FUNCTION WERE OBSERVED. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403589 EDWARDS ASCENDRA+ INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350IS23J 59583617

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention