BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHEATH UNKNOWN

    MDR report key: 10480584 · Received September 1, 2020

    Report

    Report Number
    2015691-2020-13404
    Event Type
    Death
    Date Received
    September 1, 2020
    Date of Event
    January 1, 2014
    Report Date
    August 7, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NUMBERS: 2015691-2020-13400, 2015691-2020-13401, 2015691-2020-13402.

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: MEDRANDA, GIORGIO A., KUNAL BRAHMBHATT, KEVIN MARZO, KHALED SALHAB, RICHARD SCHWARTZ, AND STEPHEN J. GREEN. "OUTCOME OF PATIENTS HAVING TRANSCATHETER MITRAL VALVE IMPLANTATION FOR THE TREATMENT OF DEGENERATED MITRAL BIOPROSTHESES." THE AMERICAN JOURNAL OF CARDIOLOGY (2020). IT WAS UNKNOWN WHICH VALVE THE PATIENT¿S RECEIVED, SAPIEN XT OR SAPIEN 3 VALVES. THE PMA NUMBERS ARE P130009 AND P140031, RESPECTIVELY. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM 2014 TO 2019. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-JAN-2014) WAS USED AS THE OCCURRENCE DATE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, AND BLEEDING ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE 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. MAJORITY OF ACCESS RELATED BLEEDING COMPLICATIONS ARE RELATED TO DISEASED VESSELS AND/OR PROCEDURAL TECHNIQUE DURING THE INSERTION OR REMOVAL OF THE SHEATH AND/OR DILATORS. THERE ARE CASES WHERE THE BLEEDING IS SIGNIFICANT AND MORE COMPLEX INTERVENTION OR TRANSFUSION IS REQUIRED TO TREAT/PREVENT A PERMANENT INJURY FROM OCCURRING. INTRA-OPERATIVE AND POST PROCEDURAL BLEEDING/ HEMORRHAGE WITHOUT AN OBVIOUS SOURCE OF BLEEDING IS A RARE BUT POTENTIALLY LIFE THREATENING COMPLICATION OF CORONARY/CARDIAC INTERVENTIONAL PROCEDURES, AND TENDS TO OCCUR MORE FREQUENTLY IN THE PRESENCE OF MORE AGGRESSIVE ANTICOAGULATION REGIMENS. POSSIBLE SOURCES INCLUDE PUNCTURE OF THE FEMORAL ARTERY ABOVE THE INGUINAL LIGAMENT AND ABOVE THE INFERIOR EPIGASTRIC ARTERY, ALLOWING THE RESULTANT BLEEDING TO EXTEND INTO THE RETROPERITONEAL SPACE, OR INADVERTENT TRAUMA OR PERFORATION OF THE ANNULAR STRUCTURE OR VENTRICLES DURING THE PROCEDURE. THIS TYPE OF BLEEDING MAY NOT BE RECOGNIZED UNTIL THE POST PROCEDURAL PERIOD. 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 TRANSFEMORAL. 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE FOR THE BLEEDING AND VASCULAR COMPLICATIONS COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED BY THE AUTHORS. 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

    PER THE JOURNAL ARTICLE, ¿OUTCOME OF PATIENTS HAVING TRANSCATHETER MITRAL VALVE IMPLANTATION FOR THE TREATMENT OF DEGENERATED MITRAL BIOPROSTHESES¿, A RETROSPECTIVE, OBSERVATIONAL STUDY WAS PERFORMED OF 26 PATIENTS WITH PRIOR SURGICAL MITRAL VALVE REPLACEMENT OR MITRAL VALVE REPAIR WITH ANNULAR RING THAT UNDERWENT TMVI USING THE BALLOON-EXPANDABLE SAPIEN XT OR SAPIEN 3 HEART-VALVE SYSTEM AT OUR INSTITUTION FROM 2014 TO 2019. OF THE 26 PATIENTS, 20 HAD PRIOR SURGICAL MITRAL VALVE REPLACEMENT AND 6 HAD PRIOR REPAIR WITH ANNULAR RING. THE PRIMARY INDICATION FOR TMVI WAS BIOPROSTHETIC MITRAL REGURGITATION IN 9 PATIENTS, BIOPROSTHETIC MITRAL STENOSIS IN 9 PATIENTS AND MIXED MITRAL DISEASE IN 8 PATIENTS. TMVI WAS PERFORMED THROUGH THE TRANSSEPTAL APPROACH IN 19 PATIENTS AND THROUGH THE TRANSAPICAL APPROACH IN 7. THERE WAS A 100% DEVICE IMPLANTATION SUCCESS RATE. DURING THE STUDY PERIOD, IN-HOSPITAL VALVE ACADEMIC RESEARCH CONSORTIUM-2 MAJOR BLEEDING OCCURRED IN 3 PATIENTS. ONE (1) PATIENT HAD POST-PROCEDURAL HEMOTHORAX, WHICH RESOLVED AFTER THORACENTESIS AND MULTIPLE TRANSFUSIONS. THE PATIENT WAS ULTIMATELY DISCHARGED HOME IN STABLE CONDITION. ONE (1) PATIENT PRESENTED WITH ACUTE FLAIL LEAFLET WITH WIDE-OPEN MR REQUIRING EXTRACORPOREAL MEMBRANOUS OXYGENATION. THE PATIENT SUFFERED FROM SIGNIFICANT ACCESS SITE BLEEDING AS WELL, REQUIRING TRANSFUSIONS, BUT WAS SUBSEQUENTLY DISCHARGED HOME. ONE (1) PATIENT WAS A TRANSFER TO THE HOSPITAL IN CARDIOGENIC SHOCK REQUIRING IMPELLA. THIS PATIENT SUFFERED FROM SIGNIFICANT ACCESS SITE BLEEDING REQUIRING TRANSFUSIONS ULTIMATELY EXPIRING ON POST-PROCEDURE DAY 16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941066 SHEATH UNKNOWN PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R