BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ESHEATH INTRODUCER SET

    MDR report key: 12109106 · Received July 2, 2021

    Report

    Report Number
    2015691-2021-03924
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 8, 2021
    Report Date
    September 15, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103194838
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6 BASED ON ADDITIONAL INFORMATION RECEIVED. THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION, DURING VISUAL INSPECTION, THE FOLLOWING OBSERVATIONS WERE SEEN ON THE RETURNED ESHEATH: ESHEATH DISTAL TIP OPENED AS DESIGNED, THE LINER EXPANDED AS DESIGNED, THE LINER REMAINS FULLY INTACT (NO TEARS OR DELAMINATION PRESENT), NO SOFT TIP DAMAGE, SCRATCHES WERE PRESENT ALONG THE ESHEATH SHAFT, NO ADDITIONAL ABNORMALITIES OBSERVED. DUE TO THE CONDITION OF RETURNED DEVICE (SHEATH EXPANDED AS DESIGNED), NO FUNCTIONAL TESTING WAS ABLE TO BE PERFORMED. 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 WRITTEN 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, AS NEEDED. 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 3 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 14 FR ESHEATH IS 5.5 MM. AS REPORTED, THE ACCESS VESSEL MLD MEASURED 5.8 MM WITH MILD CALCIFICATION AND MILD TORTUOSITY. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OF THE VASCULAR DISSECTION CANNOT BE CONFIRMED. HOWEVER, PER THE PHYSICIAN WHO PERFORMED SURGICAL REPAIR, THE VESSEL HAD SEVERE INTIMA HYPERPLASIA AND THE UNFAVORABLE ACCESS SITE MAY HAVE CAUSED THE 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. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS (B)(6) AFFILIATE, AFTER A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE IN THE AORTIC POSITION WITH A 23MM SAPIEN 3 VALVE, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) REVEALED A 5 CM DISSECTION FROM EXTERNAL ILIAC ARTERY (EIA) TO THE ACCESS SITE. AN ENDARTERECTOMY AND ANGIOPLASTY WAS PERFORMED AND A DSA SHOWED APPROXIMATELY 10 CM DISSECTION FROM THE EIA TO FEMORAL ARTERY, AND HEMODYNAMICS AT THE LOWER LEG WITH NO ABNORMALITY. UPON REMOVAL OF THE ESHEATH, THERE WAS NO DAMAGED OBSERVED. PER THE PHYSICIAN, IT IS UNKNOWN WHEN THE DISSECTION OCCURRED. PER THE PHYSICIAN THAT PERFORMED THE SURGICAL REPAIR, INTIMA HYPERPLASIA WAS SEVERE, AND AN UNFAVORABLE ACCESS SITE MAY HAVE CAUSED THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002697 EDWARDS ESHEATH INTRODUCER SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 914ESJ 63491306 00690103194838

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention