BEUDAMED
    FDA Adverse Event Death Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2873011 · Received December 13, 2012

    Report

    Report Number
    2015691-2012-18849
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE DYSFUNCTION. 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 24 FR SHEATH IS 8MM. IN THIS CASE, THE ACCESS VESSEL'S DIAMETER WAS 7.9MM, AND THE VESSELS WERE REPORTED AS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. IN THIS CASE, THE REPORTED VASCULAR COMPLICATION IS LIKELY DUE TO ADVANCEMENT OF A LARGE BORE SHEATH IN A LESS THAN ADEQUATE SIZED VESSEL, IN COMBINATION WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY. THE SEVERE CALCIFICATION IS EVIDENCED NOT ONLY BY DIFFICULTY WITH SHEATH INSERTION, BUT THE RUPTURE OF 4 COMPETITOR BALLOONS DURING TREATMENT/REPAIR OF THE VASCULAR COMPLICATION. 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 CLINICAL SPECIALIST, THE PATIENT EXPIRED DUE TO RIGHT ILIAC ARTERY RUPTURE WITH HEMORRHAGE DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). PER REPORT, PERCUTANEOUS ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY AND PREDILATATION WAS PERFORMED WITH ALL DILATORS. THE 24FR SHEATH WAS ADVANCED IN THE RIGHT FEMORAL ARTERY, BUT RESISTANCE WAS FELT AND THE SHEATH COULD NOT PASS THE BIFURCATION. THE SHEATH WAS REMOVED, AND THE ARTERY WAS DILATED ONCE AGAIN WITH THE 28FR DILATOR. THE SHEATH WAS ADVANCED AND AGAIN MET RESISTANCE JUST UNDER THE BIFURCATION. THE PHYSICIAN ATTEMPTED TO GENTLY MANIPULATE THE SHEATH BUT QUICKLY STOPPED WHEN THE SHEATH DID NOT PROGRESS. WHILE THE MEDICAL TEAM DISCUSSED OPTIONS, ANESTHESIA NOTED A SUDDEN DROP IN BLOOD PRESSURE (BP) TO THE 70'S SYSTOLIC. PROTAMINE WAS GIVEN AND A CATHETER WAS PLACED VIA THE CONTRALATERAL SIDE. THE SHEATH WAS PULLED BACK AND INJECTION REVEALED A LARGE PERFORATION. ANESTHESIA BEGAN BLOOD TRANSFUSION AND VOLUME IMMEDIATELY. A CODA AORTIC OCCLUSION BALLOON WAS ADVANCED AND INFLATED AND IMMEDIATELY RUPTURED. THREE ADDITIONAL CODA BALLOONS WERE INFLATED AT DIFFERENT LEVELS OF THE DESCENDING AORTA BUT THEY ALL RUPTURED. COVERED STENTS WERE SIMULTANEOUSLY BEING DEPLOYED FROM THE PROCEDURAL SIDE TO SEAL THE RUPTURE. DESPITE SUCCESSFUL DEPLOYMENT OF OVERLAPPING COVERED STENTS, INJECTIONS REVEALED CONTINUED BLOOD FLOW INTO THE ABDOMEN. THE VASCULAR SURGEON CONVERTED TO AN OPEN INCISION FOR REPAIR. DURING THIS TREATMENT TIME, THE PATIENT'S BLOOD PRESSURE WENT TO 40'S SYSTOLIC AND CPR WAS INITIATED. THE PHYSICIAN INFLATED A PERIPHERAL BALLOON FROM THE CONTRALATERAL SIDE, UP AND OVER THE BIFURCATION. UPON INFLATION, IT APPEARED AS THOUGH THE TEAR EXTENDED FROM THE PUNCTURE SITE ALL THE WAY UP. SURGICAL REPAIR WAS STARTED AND BLOOD VOLUME WAS BEING REPLACED VIA CELL SAVER AND RAPID INFUSER. REPAIR PROVED TO BE VERY DIFFICULT AS THE VESSEL WAS HEAVILY CALCIFIED AND DIFFICULT TO SUTURE. BLOOD VOLUME WAS BEING REPLACED WITH 25+ UNITS OF BLOOD PRODUCT GIVEN. THE PATIENT¿S BP BEGAN TO DROP ONCE AGAIN AND CPR WAS STARTED. THE PATIENT¿S ABDOMEN WAS SEVERELY TAUNT AND DISTENDED. ANESTHESIA WAS NO LONGER ABLE TO VENTILATE THE PATIENT AND SHE BECAME VERY ACIDOTIC. THE MEDICAL TEAM DECIDED TO STOP ALL EFFORTS AND THE PATIENT QUICKLY EXPIRED ON THE TABLE. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: PER REPORT, THE MINIMUM LUMINAL DIAMETER OF THE VESSEL WAS 7.9MM IN A VERY FOCAL LESION OF THE DISTAL EXTERNAL ILIAC ARTERY. THE VESSELS WERE NOTED TO BE HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE PATIENT WAS HEPARINIZED AND PROTAMINE WAS REVERSED AS SOON AS THE PERFORATION WAS NOTED. THE PATIENT WAS NOT ON ANY STEROID MEDICATION AND DID NOT HAVE A HISTORY OF SMOKING. THE PATIENT DID HAVE A HISTORY OF PERIPHERAL VASCULAR DISEASE (PVD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59135261

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death