BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 3023586 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19669
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS WHICH MAY REQUIRE INTERVENTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). 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 PREDILATING 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 MINIMUM LUMINAL DIAMETER WAS 6.5MM, AND THE VESSELS WERE NOTED TO BE NOT CALCIFIED AND MILDLY TORTUOUS. ALTHOUGH IT CANNOT BE CONFIRMED, THE REPORTED VASCULAR COMPLICATION WAS MOST LIKELY DUE TO ADVANCEMENT OF LARGE BORE DEVICES IN A LESS THAN INDICATED SIZED VESSEL. ADDITIONALLY, OTHER PATIENT FACTORS SUCH AS CALCIFICATION AND / OR TORTUOSITY THAT WERE NOT APPRECIABLE ON IMAGING MAY HAVE 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 FOR ALL REPORTED EVENTS 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 BY THE EDWARDS FIELD CLINICAL SPECIALIST, RESISTANCE WAS MET WHEN ADVANCING THE 23FR AND 25FR DILATORS. THE 22FR SHEATH WAS THEN INSERTED WITHOUT RESISTANCE AND THE SAPIEN VALVE WAS SUCCESSFULLY IMPLANTED. WHEN THE SHEATH WAS REMOVED, A DISRUPTION OF THE ILIAC ARTERY WAS NOTED. AN AORTIC OCCLUSION BALLOON WAS INFLATED TO OBSTRUCT BLOOD FLOW WHILE THE PHYSICIAN ATTEMPTED TO REPAIR THE AVULSION WITH COVERED STENTS. HOWEVER, WHEN THE OCCLUSION BALLOON WAS DEFLATED THE PATIENT'S BLOOD PRESSURE DECREASED RAPIDLY. THE PHYSICIAN THEN ATTEMPTED TO REPAIR THE COMMON AND EXTERNAL ILIAC ARTERY WITH A SURGICAL GRAFT, BUT THE PATIENT'S BP STILL DECREASED SIGNIFICANTLY WHENEVER THE OCCLUSION BALLOON WAS DEFLATED. A MID-LINE INCISION WAS MADE BECAUSE THE MEDICAL TEAM THOUGHT THE AORTA MAY HAVE BEEN RUPTURED. THE PHYSICIAN THEN ATTACHED AORTOBIFEMORAL BYPASS GRAFTS BELOW THE RENAL ARTERIES AND BILATERALLY TO BOTH ILIAC SYSTEMS. FOLLOWING THE AORTOBIFEMORAL BYPASS PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) STILL INTUBATED. SEVEN UNITS OF BLOOD WERE LOST DURING THE PROCEDURE. ACCESS WAS GAINED TO THE RIGHT EXTERNAL ILIAC ARTERY VIA A SURGICAL CUTDOWN. THE MINIMUM LUMINAL DIAMETER (MLD) OF THE ACCESS VESSEL WAS 6.5MM. THE PATIENT'S VESSELS WERE NOTED TO BE NOT CALCIFIED AND MILDLY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126526 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention