BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2830430 · Received November 13, 2012

    Report

    Report Number
    2015691-2012-18643
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHEATH IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. 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 7.0MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 6.1MM, AND THE VESSELS WERE NOTED TO BE MILDLY TORTUOUS. IN THIS CASE, THE LESS THAN ADEQUATE SIZE OF THE ACCESS VESSEL LIKELY CAUSED OR CONTRIBUTED TO THE ILIAC RUPTURE. 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, A RUPTURE OF THE LEFT EXTERNAL ILIAC ARTERY (LEIA) OCCURRED DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. PER REPORT, PERCUTANEOUS ACCESS WAS GAINED AND THE ACCESS SITE WAS DILATED WITH 16-25FR DILATORS. THE 22FR SHEATH WAS INSERTED WITHOUT RESISTANCE. FOLLOWING SUCCESSFUL DEPLOYMENT OF THE SAPIEN VALVE, THE DELIVERY SYSTEM WAS REMOVED AND THE SHEATH WAS PULLED BACK TO THE LEFT COMMON ILIAC ARTERY (LCIA). CONTRAST WAS INJECTED AND SHOWED NO DISRUPTION. THE SHEATH WAS RETRACTED FURTHER AND WHEN CONTRAST WAS INJECTED IN THE LEIA, A FRANK RUPTURE WAS NOTED. THE HEPARIN WAS REVERSED WITH PROTAMINE. AN ANSEL SHEATH WAS PLACED OVER THE ILIAC BIFURCATION AND AN 8MM BALLOON WAS USED TO OCCLUDE THE LCIA ABOVE THE BIFURCATION. TWO UNITS OF BLOOD WERE GIVEN AND TWO 10 X 10CM VIABOND STENTS WERE PLACED FROM THE LCIA TO THE LEFT COMMON FEMORAL ARTERY (LCFA). A CONTRAST INJECTION WAS DONE AND CLOT WAS NOTED IN THE STENT. THE PHYSICIAN DECIDED TO SURGICALLY OPEN THE LCFA TO REMOVE THE CLOT AND PERFORM A SURGICAL CLOSURE. THE SURGICAL SITE WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE MINIMUM LUMINAL DIAMETER OF THE ACCESS VESSEL WAS 6.1MM. THE ACCESS VESSEL WAS NOT CALCIFIED AND MILDLY TORTUOUS. PER REPORT, THE EVENT WAS NOT CAUSED BY A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB 9120S23 59293763

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention