BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 3120836 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20129
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED OR PERFORMED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. PER THE IFU ARRHYTHMIAS ARE KNOWN COMPLICATION OF THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. VENTRICULAR FIBRILLATION (VF) IS A LIFE THREATENING ARRHYTHMIA THAT IS TYPICALLY A COMPLICATION ASSOCIATED WITH POOR VENTRICULAR FUNCTION, ANNULAR RUPTURE/ AORTIC DISSECTION, OR INADEQUATE CORONARY PERFUSION. THE THV TRAINING GUIDE CAUTIONS THAT VF CAN OCCUR DURING RAPID VENTRICULAR PACING (RVP) AND ADVISES THE OPERATOR TO ENSURE THAT THE PATIENT¿S BLOOD PRESSURE IS ABOVE 100MMHG BEFORE STARTING RVP. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VASCULAR COMPLICATIONS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE. THE EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS. THE MANUALS ALSO NOTE THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE INSTRUCTIONS FOR USE (IFU) CONTRAINDICATE THE USE OF THE DEVICE IN PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS, SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL AND ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE THV VALVE CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE OPERATORS ARE TRAINED TO MEASURE MINIMUM VESSEL DIAMETER TAKING CALCIUM INTO ACCOUNT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 22F SHEATH IS 7.0MM. IN THIS CASE, THE ACCESS VESSEL WAS 7.0MM AND THE VESSELS WERE INDICATED TO BE MILDLY CALCIFIED AND NON TORTUOUS. THE TRANSFEMORAL TAVR PROCEDURE REQUIRES THE INSERTION OF LARGE BORE DEVICES, AND THERE IS A RISK THAT PLACEMENT OF THE SHEATH AND/OR DILATORS MAY RESULT IN OR CONTRIBUTE TO VESSEL DAMAGE. IN THIS CASE, THE EXACT CAUSE FOR THE REPORTED DISSECTION CANNOT BE CONFIRMED; HOWEVER, IT IS LIKELY THAT A COMBINATION OF THE BORDERLINE SIZE OF THE ACCESS VESSEL IN COMBINATION WITH CALCIFICATION OR TORTUOSITY THAT WAS NOT APPRECIABLE ON IMAGING CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE EXACT CAUSE OF THE VF EVENT CANNOT BE DETERMINED BUT COULD BE RELATED TO PATIENT (ADVANCED AGE, HIGH RISK) AND PROCEDURAL (RAPID PACING DURING VALVE DEPLOYMENT, BLEEDING FROM THE VASCULAR INJURY) FACTORS. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS HAVE BEEN UNSUCCESSFUL. POST TAVR THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION. THERE WAS NO ALLEGATION THAT THE DEATH WAS RELATED TO THE VALVE, SHEATH OR ANY OTHER EDWARDS¿S DEVICE. SHOULD THE INFORMATION BE RECEIVED THIS CASE WILL BE REOPENED AND FURTHER INVESTIGATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPIRED SEVEN DAYS POST TAVR DUE TO TAVR RELATED VASCULAR COMPLICATIONS. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST (CS), DURING THE TRANSFEMORAL TAVR PROCEDURE, THE PHYSICIAN REPORTED FEELING RESISTANCE AS THE SHEATH WAS BEING REMOVED. ONCE THE SHEATH WAS REMOVED, PART OF THE ILIAC ARTERY CAME OUT ATTACHED TO THE SHEATH. THE PATIENT BLED A FAIR AMOUNT AND WENT INTO VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS SHOCKED AND WAS GIVEN 4 UNITS OF BLOOD. A PERMANENT PACEMAKER WAS NOT IMPLANTED. A ILIO-FEM BYPASS WAS PERFORMED TO REPAIR THE VESSEL. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221942 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23 59450824

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention