BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTRODUCER SET UNKNOWN

    MDR report key: 8362348 · Received February 22, 2019

    Report

    Report Number
    2015691-2019-00612
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED 1 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00610. THIS EVENT IS RELATED TO THE DISLOCATION/EMBOLIZATION. PLEASE REFERENCE RELATED 2 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00611. THIS EVENT IS RELATED TO THE STROKE. PLEASE REFERENCE RELATED 3 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00612. THIS EVENT IS RELATED TO THE MAJOR AND MINOR VASCULAR COMPLICATIONS. PLEASE REFERENCE RELATED 4 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00614. THIS EVENT IS RELATED TO THE CONDUCTION DISORDERS. PLEASE REFERENCE RELATED 5 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00616. THIS EVENT IS RELATED TO THE VALVE IN VALVE PROCEDURE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THIS IS THREE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THIS EVENT IS RELATED TO THE MAJOR AND MINOR VASCULAR COMPLICATIONS. REFERENCE ARTICLE: SCHERNER, MAXIMILIAN, NAVID MADERSHAHIAN, KATHRIN KUHR, STEPHAN ROSENKRANZ, ELISABETH STÖGER, PARWIS RAHMANIAN, YEONGHOON CHOI ET AL. "AORTIC VALVE REPLACEMENT AFTER PREVIOUS HEART SURGERY IN HIGH-RISK PATIENTS: TRANSAPICAL AORTIC VALVE IMPLANTATION VERSUS CONVENTIONAL AORTIC VALVE REPLACEMENT¿A RISK-ADJUSTED AND PROPENSITY SCORE-BASED ANALYSIS." THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 148, NO. 1 (2014): 90-97. 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 THIS ADVERSE EVENT.  THE ARTICLE DID NOT HAVE DETAILS OF THE EVENTS. THESE EVENTS WERE LISTED AS 30 DAY OUTCOMES. THE CAUSE OF THE VASCULAR COMPLICATION IS UNKNOWN; HOWEVER, THE MECHANISMS DESCRIBED ABOVE MAY HAVE CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), THROUGH THE REVIEW OF THE MEDICAL ARTICLE ¿AORTIC VALVE REPLACEMENT AFTER PREVIOUS HEART SURGERY IN HIGH-RISK PATIENTS: TRANSAPICAL AORTIC VALVE IMPLANTATION VERSUS CONVENTIONAL AORTIC VALVE REPLACEMENT¿A RISK-ADJUSTED AND PROPENSITY SCORE-BASED ANALYSIS¿ CORRESPONDING AUTHOR DR. MAXIMILIAN SCHERNER ET AL. THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO EDWARDS DEVICES: IN THE GROUP OF PATIENTS WHO UNDERWENT TA-AVI AS A SECONDARY CARDIAC OPERATION (REDO TA-AVI) WITH AN EDWARDS SAPIEN VALVE, THE FOLLOWING 30-DAY OUTCOMES WERE OBSERVED: 1 PATIENT WAS CONVERTED TO CONVENTIONAL AVR DUE TO VALVE DISLOCATION/EMBOLIZATION AND EXPIRED. 1 PATIENT HAD A STROKE. 3 PATIENTS HAD BOTH MAJOR AND MINOR VASCULAR COMPLICATIONS. 1 PATIENT DEVELOPED A NEW LEFT BUNDLE BRANCH BLOCK AND 3 PATIENTS REQUIRED NEW PERMANENT PACEMAKER IMPLANTATION DUE TO NEW ATRIOVENTRICULAR BLOCK, THIRD DEGREE. 2 PATIENTS REQUIRED UNPLANNED VALVE-IN-VALVE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157232 EDWARDS INTRODUCER SET UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES EDWARDS INTRODUCER SET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention