BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE INTRODUCER SHEATH SET

    MDR report key: 4241894 · Received November 10, 2014

    Report

    Report Number
    2015691-2014-02662
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY BY EDWARDS LIFESCIENCES, VASCULAR COMPLICATIONS ARE A WELL RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. EDWARDS HAS REVIEWED MANY REPORTS, INCLUDING SCREENING DATA RECORDS AND SOURCE DOCUMENTATION OF VASCULAR COMPLICATIONS AND HAS FOUND THAT THE ROOT CAUSE IS TYPICALLY RELATED TO A COMBINATION OF VESSEL SIZE, TORTUOSITY AND CALCIFICATIONS. ALTHOUGH THE INCIDENCE IS DECREASING WITH SMALLER SHEATH/DELIVERY SYSTEM SIZES AND PHYSICIAN EXPERIENCE, THERE WILL CONTINUE TO BE CASES IN WHICH VASCULAR COMPLICATIONS WILL OCCUR. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT 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. IT ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL/ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN VALVE CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE OPERATORS ARE TRAINED TO MEASURE MINIMUM VESSEL DIAMETER TAKING CALCIUM INTO ACCOUNT. THE PHYSICIAN TRAINING MANUAL ALSO LISTS THE MINIMUM RECOMMENDED VESSEL SIZE FOR EACH SIZE DEVICE. DESPITE THE BEST SCREENING TOOLS, A SMALL PERCENTAGE OF PATIENTS WILL HAVE FEMORAL/ILIAC VESSELS THAT ARE NOT AMENABLE TO THE TRANS-FEMORAL APPROACH OR WHERE INCREASED RESISTANCE IS ENCOUNTERED DURING INSERTION OF DEVICES. IN MANY CASES, THE VESSEL MINIMUM LUMINAL DIAMETER (MLD) MAY BE BORDERLINE OR BELOW THE INDICATED SIZE. IN ADDITION, SIGNIFICANT CALCIFICATION AND/OR TORTUOSITY, NOT ALWAYS APPRECIABLE ON IMAGING, COULD BE CONTRIBUTING FACTORS TO THE EVENT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 20FR ESHEATH IS 7MM. IN THIS CASE, THE ACCESS VESSEL MINIMUM LUMINAL DIAMETER WAS 6.9MM, AND THE VESSEL WAS REPORTED AS MILDLY CALCIFIED AND MILDLY TORTUOUS. THE CASE PHYSICIAN ATTRIBUTED THE VESSEL DISSECTION AND THE DIFFICULTY ACQUIRING HEMOSTASIS TO A RECENT AND PRE-TAVR PSEUDOANEURYSM REPAIR THAT WAS NOT SEEN ON IMAGING PRIOR TO THE TAVR CASE. 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

    DURING A TRANSFEMORAL TAVR PROCEDURE, UPON REMOVAL OF THE 20FR ESHEATH, HEMOSTASIS WAS DIFFICULT. ANGIOGRAPHY CONFIRMED A DISSECTION AT THE RIGHT COMMON FEMORAL ARTERY (RCFA). A DACRON PATCH WAS SURGICALLY PLACED TO REPAIR THE VESSEL. INITIALLY PERCUTANEOUS ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY. THE DILATORS AND ESHEATH WERE INSERTED WITHOUT DIFFICULTY. AFTER THE VALVE WAS DEPLOYED, 3 PERCLOSE SUTURES WERE PLACED, AND MANUAL PRESSURE WAS APPLIED. THE SURGEON WAS UNABLE TO GET ARTERIAL HEMOSTASIS, THEREFORE A 22FR DILATOR WAS REINSERTED OVER A STORQ WIRE, AND HEMOSTASIS WAS ACHIEVED. ANGIOGRAPHY WAS PERFORMED, AND A DISSECTION WAS NOTED IN THE RCFA. DURING THE SURGICAL CUTDOWN, THE SURGEON HAD DIFFICULTY VISUALIZING A PORTION OF THE RFA FOR THE CLAMP. THE PATIENT WAS NOTED TO HAVE HAD A RECENT PSEUDOANEURYSM REPAIR THAT LOOKED AS IF IT HAD BEEN REPAIRED WITH SOME SORT OF "THROMBIN OR GLUE." THIS WAS A NEW FINDING TO THE SURGICAL TEAM, AS THEY WERE UNAWARE OF THIS PRIOR TO TAVR. THE PRE-TAVR FEMORAL ANGIOGRAPHY OF THE RIGHT SIDE DID NOT REVEAL A PSEUDOANEURYSM. THE PRIOR AND APPARENTLY RECENT PSEUDOANEURYSM REPAIR CAUSED DIFFICULTY GETTING HEMOSTASIS WITH PERCLOSE. ANGIOGRAPHY POST SURGICAL REPAIR OF THE VESSEL DID NOT SHOW ANY OTHER VESSEL INJURY. PERIPHERALPULSES WERE PRESENT ON DOPPLER. THE PATIENT WAS EXTUBATED IN THE OR, AND TRANSPORTED TO THE ICU IN STABLE CONDITION. THE DILATORS AND THE ESHEATH WERE INSPECTED PRIOR TO USE AND NOTHING UNUSUAL WAS NOTED. THE ACCESS VESSEL MINIMUM LUMINAL DIAMETER WAS 6.9MM. THE VESSEL WAS MILDLY CALCIFIED AND MILDLY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723660 EDWARDS EXPANDABLE INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 920ES29 59845735

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention