BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX DILATOR KIT

    MDR report key: 3102652 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20036
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRE
    PMA / PMN Number
    K093554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DILATOR KIT WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED/PERFORMED AS THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. DESPITE THE BEST SCREENING TOOLS, A SMALL PERCENTAGE OF PATIENTS WILL HAVE FEMORAL/ILIAC VESSELS THAT ARE NOT AMENABLE TO THE TRANS-FEMORAL APPROACH OR WHERE INCREASED RESISTANCE IS ENCOUNTERED DURING INSERTION OF DEVICES. THIS MAY BE DUE TO EXCESSIVE CALCIFICATION, TORTUOSITY, AND/OR SMALL VESSEL DIAMETER. WHEN DIFFICULTY IS ENCOUNTERED INSERTING/ADVANCING THE DILATOR, IT IS ROUTINE TO TROUBLESHOOT. THIS MAY REQUIRE EXCHANGE OF THE DEVICE OVER A GUIDE WIRE; HOWEVER, THIS CAN BE PERFORMED WITH MINIMAL DELAY IN TREATMENT AND LITTLE RISK TO THE PATIENT. IN THIS CASE, THE PHYSICIAN ATTEMPTED TO DILATE THE VESSEL IN ORDER TO ALLOW SAFE PASSAGE OF THE DEVICE WHICH RESULTED IN THE VESSEL RUPTURE. PER THE INSTRUCTIONS FOR USE (IFU) AND THE PATIENT SCREENING MANUAL, THE DILATOR KIT IS CONTRAINDICATED FOR TORTUOUS OR CALCIFIED VESSELS THAT WOULD PREVENT SAFE ENTRY OF A DILATOR. ADDITIONALLY THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER PERIPHERAL VESSEL ASSESSMENT, TAKING INTO CONSIDERATION CALCIFICATION, TORTUOSITY, AND MINIMUM VESSEL DIAMETER. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL AND ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN 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. IN THIS CASE, THE PATIENT WAS REPORTED TO HAVE MODERATE VESSEL CALCIFICATION AND MILD VESSEL TORTUOSITY. THE REPORTED VESSEL SIZE WAS 6.9MM AND THE OUTER DIAMETER (OD) OF THE 20F DILATOR IS 6.7MM. THE RECOMMENDED MINIMAL VESSEL SIZE FOR INSERTION OF A 22FR SHEATH IS 7.0MM. THE EXACT CAUSE FOR THE REPORTED RUPTURE CANNOT BE CONFIRMED; HOWEVER, IT WAS LIKELY RELATED TO VESSEL CHARACTERISTICS (SMALL VESSEL SIZE WITH MODERATE CALCIFICATION). 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. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING THE TRANSFEMORAL TAVR PROCEDURE, UPON REMOVAL OF THE 20F DILATOR, AN ANGIOGRAM REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC. IT WAS REPORTED AT THE BEGINNING OF THE PROCEDURE THE PHYSICIAN EXPERIENCED DIFFICULTIES INSERTING THE 18F DILATOR WITH SOME SCORING PRESENT UPON REMOVAL. THE 20F DILATOR WAS THEN INSERTED WITH SOME RESISTANCE AND A SIGNIFICANT DROP IN BLOOD PRESSURE WAS NOTICED. AN ANGIOGRAM REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC. IN ORDER TO REPAIR THE VESSEL, A 10X40X80 FOX CROSS BALLOON WAS INTRODUCED FROM THE LEFT SIDE TO CONTROL BLEEDING ON THE RIGHT SIDE AND HELP MAINTAIN BLOOD PRESSURE. A COMPLETE SE 10X60X80CM STENT WAS THEN USED AT THE RIGHT EXTERNAL ILIAC AND NORMAL FLOW WAS THEN ACHIEVED. THE TEAM THEN DECIDED TO ABORT THE PROCEDURE. THE PATIENT WAS ADMINISTERED 11 UNITS OF BLOOD THROUGHOUT THE PROCEDURE AND VASOPRESSORS WERE ALSO ADMINISTERED. AT THE CONCLUSION OF THE CASE, THE PATIENT WAS STABLE AND WAS TRANSFERRED TO THE UNIT FOR POST OP MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204290 RETROFLEX DILATOR KIT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE EDWARDS LIFESCIENCES 9100DKS7 59374036

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention