BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE INTRODUCER SHEATH SET

    MDR report key: 7117226 · Received December 14, 2017

    Report

    Report Number
    2015691-2017-04277
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    June 6, 2014
    Report Date
    November 23, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE SAPIEN XT (9300TFX) OR SAPIEN 3 (9600TFX) VALVE WAS IMPLANTED, THEREFORE THE MODEL OF THE EXPANDABLE INTRODUCER SHEATH SET IS UNKNOWN. G5: PMA P130009 OR PMA P140031. INVESTIGATION IS ONGOING. BIBLIOGRAPHY: UNZUÉ, LEIRE, ET AL. "OUTCOMES OF PATIENTS AT ESTIMATED LOW SURGICAL RISK UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH BALLOON-EXPANDABLE PROSTHESES." CARDIOVASCULAR REVASCULARIZATION MEDICINE (2017).

    Additional Manufacturer Narrative · 1

    REF. MFG REPORT NUMBERS: 2015691-2017-04275, 2015691-2017-04276, 2015691-2017-04278, 2015691-2017-04279.

    Additional Manufacturer Narrative · 1

    THE SHEATHS WERE DISCARDED AND WERE THEREFORE NOT RETURNED TO EDWARDS FOR EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL CASE INFORMATION WERE MADE, HOWEVER, THE INFORMATION WAS NOT FORTHCOMING. 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 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THESE ADVERSE EVENTS. THE EXACT REASONS FOR THE ¿MINOR VASCULAR COMPLICATIONS¿ ARE UNKNOWN BUT MAYBE RELATED TO THE FACTORS MENTIONED ABOVE. 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 AFFILIATE IN EUROPE, A JOURNAL ARTICLE TITLED, "OUTCOMES OF PATIENTS AT ESTIMATED LOW SURGICAL RISK UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH BALLOON-EXPANDABLE PROSTHESES" REPORTED THAT POST TAVR PROCEDURE (DATES UNKNOWN) IN THE AORTIC POSITION, NINE PATIENTS HAD ¿MINOR VASCULAR COMPLICATIONS¿ WITH FOUR PATIENTS IN WHICH AN ADVANTA STENT WAS REQUIRED AND FIVE IN WHICH INTERNAL HEMOSTASIS WITH A PROLONGED BALLOON INFLATION WAS PERFORMED AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895486 EDWARDS EXPANDABLE INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention