BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2802315 · Received October 24, 2012

    Report

    Report Number
    2015691-2012-18535
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL REPORT, THE MEDICAL RECORDS PERTAINING TO THE EVENT WERE OBTAINED. PER THE CARDIOLOGY PROCEDURE REPORT, PERCUTANEOUS ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY AND THREE PERCLOSE CLOSURE DEVICES WERE DEPLOYED. SERIAL DILATION WAS PERFORMED WITH NO NOTED DIFFICULTY. FOLLOWING DEPLOYMENT OF THE SAPIEN VALVE, A POWER INJECTOR WAS HOOKED UP TO THE RETROFLEX3 SHEATH AND A ROSCH INFERIOR MESENTERIC (RIM) CATHETER AND AN ANGLED GLIDEWIRE WERE ADVANCED INTO THE LEFT ARTERIAL SHEATH. WHEN THE RETROFLEX3 SHEATH WAS PULLED BACK THERE WAS NO EVIDENCE OF DISSECTION OR BLEEDING. THE RIM CATHETER WAS ADVANCED AND THE ANGLED GLIDEWIRE WAS EXCHANGED FOR A SUPRACORE WIRE. AT THIS TIME THE RIM CATHETER WAS REMOVED AND A 6FR ANSEL SHEATH WAS ADVANCED OVER THE SUPRACORE WIRE AND AROUND THE RIGHT EXTERNAL ILIAC ARTERY. A BALLOON WAS PASSED THROUGH THE SHEATH AND INFLATED TWO ATMOSPHERES IN THE COMMON ILIAC ARTERY. SUBSEQUENT INJECTION THROUGH THE RETROFLEX3 SHEATH REVEALED SUCCESSFUL OCCLUSION OF FLOW WITH THE BALLOON AND NO BLEEDING. THE RETROFLEX3 SHEATH WAS REMOVED FROM THE PATIENT AND THE PERCLOSE DEVICES WERE SUTURED INTO PLACE. THEN, AS THE ANSEL SHEATH WAS PULLED BACK AROUND THE LEFT COMMON ILIAC ARTERY, THE PHYSICIANS NOTICED SIGNIFICANT STAINING AT THE LEVEL OF THE AORTA. CONTRAST INJECTION THROUGH THE ANSEL SHEATH REVEALED A DISSECTION FLAP IN THE RIGHT COMMON ILIAC ARTERY. A SUBSEQUENT ABDOMINAL AORTIC ANGIOGRAM REVEALED THAT THE DISSECTION DID NOT EXTEND INTO THE AORTA. A BALLOON EXPANDABLE STENT WAS USED TO REPAIR THE DISSECTION. THE BALLOON WAS REMOVED, AND SUBSEQUENT ANGIOGRAPHY DEMONSTRATED EXCELLENT RESULTS, WITH NO LIMITATION OF FLOW IN THE LEFT COMMON FEMORAL ARTERY AND NO COMPROMISE OF THE HYPOGASTRIC ARTERY. 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. IN THIS CASE, THE ROOT CAUSE OF THE RIGHT COMMON ILIAC ARTERY DISSECTION CANNOT BE CONFIRMED. HOWEVER, THE EDWARDS RF3 SHEATH WAS INSERTED THROUGH THE LFA AND THE DISSECTION OCCURRED ON THE RIGHT. AS EVIDENCED BY THE LOCATION AND TIMING THE DISSECTION WAS NOTED, IT APPEARS THAT THE DISSECTION WAS RELATED TO THE PULLING BACK OF THE NON-EDWARDS ANSEL SHEATH. CONSEQUENTLY, IT DOES NOT APPEAR THAT THE RETROFLEX3 SHEATH CAUSED OR CONTRIBUTED TO THE REPORT DISSECTION. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, UPON REMOVAL OF THE SHEATH AT THE END OF THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A DISSECTION TO THE RIGHT EXTERNAL ILIAC ARTERY (REIA) WAS NOTED, WHICH REQUIRED THE PLACEMENT OF A COVERED STENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23 59255093

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention