BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET

    MDR report key: 2862110 · Received December 7, 2012

    Report

    Report Number
    2015691-2012-18781
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHEATH WAS NOT RETURNED FOR EVALUATION AS IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE DEVICE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE EDWARDS SAPIEN/RF3 TRAINING MANUAL INSTRUCTS ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS. THE PHYSICIAN TRAINING MANUAL ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 24 FR SHEATH IS 8MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 8.0 MM, AND THE VESSELS WERE NOTED TO BE MILDLY CALCIFIED AND MILDLY TORTUOUS. IT IS ALSO POSSIBLE THAT THE BORDERLINE SIZE OF THE VESSEL IN COMBINATION WITH MILD CALCIFICATION AND MILD TORTUOSITY CONTRIBUTED TO 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. COMPLAINT HISTORIES 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, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, AFTER THE VALVE WAS SUCCESSFULLY DEPLOYED AND THE RF3 DELIVERY SYSTEM REMOVED, THE EDWARDS SHEATH WAS PULLED BACK, AND A CONTRAST INJECTION REVEALED A DISSECTION IN THE LEFT COMMON ILIAC. TWO VIABAHN COVERED STENTS WERE DEPLOYED TO COVER THE DISSECTION. FINAL INJECTION SHOWED GOOD RUNOFF. THE LEFT GROIN WAS CLOSED IN SURGICAL FASHION AND THE PATIENT WAS TRANSFERRED TO THE CVOR UNIT IN STABLE CONDITION. FURTHER DETAILS INDICATED THAT THE EDWARDS DILATORS AND SHEATH WERE ADVANCED THROUGH THE LEFT GROIN ACCESS. AFTER SUCCESSFUL DEPLOYMENT OF THE VALVE AND REMOVAL OF THE RF3 DELIVERY SYSTEM, CONTRAST INJECTION REVEALED A DISSECTION IN LEFT COMMON ILIAC. THE SHEATH WAS REMOVED AND TWO VIABAM 8 MM COVERED STENTS DEPLOYED IN LEFT COMMON ILIAC. FINAL INJECTION SHOWED GOOD RUNOFF. LEFT GROIN WAS SURGICALLY CLOSED, AND RIGHT GROIN USED PERCLOSE DEVICES FOR GROIN HEMOSTASIS. PATIENT WAS TRANSFERRED TO CVOR UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59264898

    Patients

    Seq Age Sex Outcome Treatment
    1 77 Required Intervention