BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSFEMORAL SHEATH

    MDR report key: 8139512 · Received December 6, 2018

    Report

    Report Number
    2015691-2018-05122
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    August 1, 2012
    Report Date
    November 14, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    IN THIS CASE, THE EXACT DEVICE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS TF SHEATH. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS TA SHEATH: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031 - EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. 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, 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 IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE REPORTED VASCULAR COMPLICATIONS. THE AUTHORS DID NOT SPECIFY TO WHICH OF THE DEVICES USED DURING THE TAVR PROCEDURE THESE EVENTS WERE ASSOCIATED. THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. 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. REFERENCE MFG. REPORT NO. 2015691-2018-05121. BIBLIOGRAPHY: WILLIAM TOPPEN, M., WILLIAM SUH, M., OLCAY AKSOY, M., & PEYMAN BENHARASH, M. E. (2018). VASCULAR COMPLICATIONS IN THE SAPIEN 3 ERA: CONTINUED "ROLD" OF TRANSAPICAL APPROACH TO TRANSCATHETER AORTIC VALVE "REPLACMENT". SEMINARS IN THORACIC AND CARDIOVASCULAR SURGERY, 144-149.

    Description of Event or Problem · 1

    AS REPORTED THROUGH ARTICLE LITERATURE, "VASCULAR COMPLICATIONS IN THE SAPIEN 3 ERA: CONTINUED ROLE OF TRANSAPICAL APPROACH TO TRANSCATHETER AORTIC VALVE REPLACEMENT", A TOTAL OF 279 PATIENTS WERE IDENTIFIED IN THE TRANSCATHETER VALVE THERAPY REGISTRY DURING THE DESIGNATED STUDY PERIOD IN A SINGLE CENTER RETROSPECTIVE REVIEW BETWEEN AUGUST 2012 TO JULY 2016. FOUR PATIENTS WERE EXCLUDED BECAUSE OF ABORTED PROCEDURES. ALL 275 REMAINING PATIENTS WERE INCLUDED FOR ANALYSIS. VASCULAR COMPLICATIONS OCCURRED AT A RATE OF 14% IN THE S3 ERA VS 16% IN THE PRE-S3 ERA. VASCULAR COMPLICATIONS INCLUDED VASCULAR PERFORATION, DISSECTION, FLOW-LIMITING STENOSIS, UNPLANNED VASCULAR SURGERY, SIGNIFICANT POST-PROCEDURAL BLEEDING, HEMATOMA AT THE ACCESS SITE, AND RETROPERITONEAL BLEED. IN THE PRE-SAPIEN 3 ERA A TOTAL OF 19 PATIENTS EXPERIENCED VASCULAR COMPLICATIONS. IN THE SAPIEN 3 ERA A TOTAL OF 21 PATIENTS EXPERIENCED VASCULAR COMPLICATIONS. THESE MDR REPRESENTS EVENTS REPRESENT 10 OF THE PRE-S3 AND 14 OF THE S3 PATIENTS WITH VASCULAR COMPLICATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980108 EDWARDS TRANSFEMORAL SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention