BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS UNKNOWN SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8362262 · Received February 22, 2019

    Report

    Report Number
    2015691-2019-00611
    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 TWO OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THIS EVENT IS RELATED TO THE STROKE. 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. PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES.  ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, STROKE IS RECOGNIZED IN THE LITERATURE AS A WELL-KNOWN COMPLICATION IN A SMALL NUMBER OF PATIENTS UNDERGOING TAVR. RISK FACTORS CORRELATING WITH A NUMBER OF PATIENT CO-MORBIDITIES HAVE BEEN IDENTIFIED. ALTHOUGH IN MANY CASES THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, STROKES DURING TAVR ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA-PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING TAVR DEMONSTRATED THAT THE MAJORITY OF PROCEDURAL EMBOLIC EVENTS OCCURRED DURING BALLOON VALVULOPLASTY, MANIPULATION OF CATHETERS ACROSS THE AORTIC VALVE, AND VALVE IMPLANTATION.   AN ANALYSIS IN PATIENTS UNDERGOING VALVE SURGERY REVEALED FOUR BASELINE CHARACTERISTICS AND TWO PROCEDURAL EVENTS THAT WERE ASSOCIATED WITH EARLY POST-PROCEDURE STROKE: FEMALE SEX, EF < 30%, DIABETES, AGE OLDER THAN 70 YEARS, BYPASS PROCEDURE TIME> 120 MIN, AND CALCIFICATION OF THE ASCENDING AORTA. PREDICTORS OF LATE STROKE HAVE INCLUDED FEMALE SEX, AGE OLDER THAN 75 YEARS, ATRIAL FIBRILLATION, AND A HISTORY OF OR CURRENT SMOKING. THERE WERE NO IMPORTANT DIFFERENCES IN THE FREQUENCY OF LATE STROKES BETWEEN TAVR AND AVR PATIENTS.  AFTER TAVR, THERE APPEARS TO BE A MORE SIGNIFICANT PROPORTION OF EARLY STROKES OCCURRING < 24 H POST-PROCEDURE, BUT TAVR PATIENTS WITH MULTIPLE CO MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. 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 STROKE 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.

    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
    155635 EDWARDS UNKNOWN SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN SAPIEN TRANSCATHETER HEART VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other