BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8161538 · Received December 13, 2018

    Report

    Report Number
    2015691-2018-05249
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 19, 2018
    Report Date
    November 19, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2018-05247, 2015691-2018-05248, 2015691-2018-05250, 2015691-2018-05252. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE ARE LISTED BELOW;  SECTION OF THIS REPORT WILL REMAIN BLANK. P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE WITH COMMANDER DELIVERY SYSTEM (TF INDICATION). (B)(4).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE ARE LISTED BELOW: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT¿ TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE WITH COMMANDER DELIVERY SYSTEM (TF INDICATION). 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 TS 39110, 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.  INVESTIGATION RESULTS ARE INCONCLUSIVE, AS RELATIVE PATIENT AND PROCEDURAL INFORMATION WAS NOT PROVIDED, SO THE EXACT CAUSE OF THE VESSEL INJURY IS UNKNOWN. HOWEVER, THE VESSEL INJURY COULD BE RELATED TO THE MECHANISMS DESCRIBED 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 THROUGH ARTICLE ¿COMPARISON OF 30-DAY OUTCOMES OF TRANSFEMORAL VERSUS TRANSAPICAL APPROACH¿, DATA WAS COLLECTED RETROSPECTIVELY ON CONSECUTIVE PATIENTS WHO UNDERWENT TAVR BY THE TF OR TA APPROACH. THE PRIMARY ENDPOINTS INCLUDED THE FOLLOWING: ALL-CAUSE MORTALITY; STROKE; MAJOR AND LIFE THREATENING BLEEDING; RENAL FAILURE; VALVE-RELATED DYSFUNCTION REQUIRING AN INTERVENTION; AND MODERATE TO SEVERE PARAVALVULAR LEAK AND MAJOR VASCULAR COMPLICATIONS AT 30 DAYS. THE SECONDARY ENDPOINTS INCLUDED NEED FOR A PACEMAKER AND HOSPITAL LENGTH OF STAY. THIRTEEN PATIENTS (10.6%) REQUIRED INSERTION OF A PERMANENT PACEMAKER (TF 6 [9.1%] VS TA 7 [12.3%], P ¼ 0.574). TWO PATIENTS HAD CORONARY OCCLUSION, 1 IN BOTH GROUPS. INTRA PROCEDURAL DATA HAD 13 UNPLANNED MAJOR AND MINOR VASCULAR INTERVENTIONS. 5 STROKES WERE REPORTED, INCLUDING THE 2 DEATHS. TWO MYOCARDIAL INFARCTIONS WERE REPORTED. NINE REGURGITATION PARAVALVULAR LEAK (PVL) WERE REPORTED, BUT THERE IS NO INDICATION OF INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001741 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention