BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET

    MDR report key: 2862119 · Received December 7, 2012

    Report

    Report Number
    2015691-2012-18782
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHEATH IS NOT AVAILABLE FOR EVALUATION AS IT WAS NOT RETURNED BY THE SITE; HOWEVER THERE WAS NO REPORT OF A DEVICE MALFUNCTION. 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 22 FR SHEATH IS 7MM. IN THIS CASE, THE ACCESS VESSEL¿S DIAMETER WAS 7 MM, AND THE VESSELS WERE NOTED TO BE MILDLY TORTUOUS AND MILDLY CALCIFIED. THE ROOT CAUSE FOR THE REPORTED DISSECTION CANNOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE THAT THE BORDERLINE SIZE OF THE VESSEL IN COMBINATION WITH MILD CALCIFICATION AND MILD TORTUOSITY CONTRIBUTED TO THE EVENT. THE DISSECTION WAS SUCCESSFULLY TREATED BY THE PLACEMENT OF THREE STENTS. 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

    PER THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, AFTER THE SAPIEN VALVE WAS IMPLANTED SUCCESSFULLY, A PERFORATION OF THE LEFT EXTERNAL ILIAC WAS FOUND WHEN THE 22 FR SHEATH WAS REMOVED. THE LEFT GROIN WAS USED TO OBTAIN PERCUTANEOUS ACCESS FOR THE PLANNED 22F TAVR SHEATH. THE 23MM VALVE WAS DEPLOYED WITHOUT ANY DIFFICULTY AND THE DELIVERY SYSTEM REMOVED. THE 22F SHEATH WAS REMOVED WITH SOME DIFFICULTY. ONCE THE SHEATH WAS RETRACTED BELOW THE LEFT COMMON ILIAC AN ANGIOGRAM WAS PERFORMED FROM THE CONTRALATERAL SIDE SHOWING A PERFORATION OF THE LEFT EXTERNAL ILIAC. A COVERED STENT WAS INSERTED TO OCCLUDE THE PERFORATION. AN INJECTION OF CONTRAST WAS PERFORMED FROM THE CONTRALATERAL SIDE SHOWING NO FURTHER PERFORATION. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE VESSEL WAS DESCRIBED AS MILDLY CALCIFIED AND MILDLY TORTUOUS. NOTHING ABNORMAL WAS NOTICED ABOUT THE SHEATH PRIOR TO USE, AND THE SHEATH WAS INTRODUCED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23 59300867

    Patients

    Seq Age Sex Outcome Treatment
    1 91 Required Intervention