BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 20897621 · Received December 10, 2024

    Report

    Report Number
    2015691-2024-09454
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    July 10, 2024
    Report Date
    December 10, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE FOR JOURNAL ARTICLE: HOLLOWAY J, LEE M, STEPHENS B, BYUN WY, SAKLAYEN S, ANAM K, AWAD H. ANESTHETIC MANAGEMENT OF INTRACARDIAC MIGRATION OF MEDICAL DEVICES. J CARDIOTHORAC VASC ANESTH. 2024 JUL 11:S1053-0770(24)00452-X. THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, THE JOURNAL ARTICLE WAS PUBLISHED ON JULY 10, 2024. FOR THIS REASON, JULY 10, 2024 WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT MODEL NUMBER OF THE VALVE IMPLANTED IS NOT AVAILABLE. THEREFORE, SECTION D1 (BRAND NAME) AND D4 (ADDITIONAL DEVICE INFORMATION - MODEL NUMBER) 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: P110021 - EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; P140031 - EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM; P140031 - EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE SYSTEM. PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS AND CONDUCTION SYSTEM DEFECTS WHICH MAY OR MAY NOT REQUIRE A PERMANENT PACEMAKER IMPLANTATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, BIOPROSTHETIC HEART VALVES, AND THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY EXPLAIN THESE COMPLICATIONS OF THE TVR PROCEDURE. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN AN EDWARDS LIFESCIENCES CLINICAL TECHNICAL SUMMARY, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE COMORBID STATUS, THE DEGREE, AND BULKINESS OF ANNULAR CALCIFICATION, INTERVENTRICULAR SEPTAL THICKNESS, HISTORY OF ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AORTIC VALVE REPLACEMENT (AVR), WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND SUTURE PLACEMENT IN THE PROXIMITY OF THE ATRIOVENTRICULAR (AV) NODE OR THE BUNDLES, THE TRANSCATHETER HEART VALVE MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING THV OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME, THE EVENT MAY BE DUE TO ONE OR MORE OF THE MECHANISMS DESCRIBED ABOVE. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED FROM THE JOURNAL ARTICLE "ANESTHETIC MANAGEMENT OF INTRACARDIAC MIGRATION OF MEDICAL DEVICES", A 65-YEAR-OLD FEMALE WITH A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CHRONIC KIDNEY DISEASE, TYPE 2 DIABETES, HYPERTENSION, HISTORY OF PULMONARY EMBOLUS ON ANTICOAGULATION, SLEEP APNEA, AND HEART FAILURE WITH PRE-SERVED EJECTION FRACTION PRESENTED FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR DECOMPENSATED AORTIC STENOSIS. A NON-EDWARDS VALVE WAS FIRST IMPLANTED AND IMMEDIATELY DISLODGED ABOVE THE ANNULUS. A SAPIEN VALVE WAS THEN PREPARED AND DEPLOYED. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED ADEQUATE VALVE FUNCTION WITHOUT SIGNIFICANT REGURGITATION. THE PATIENT EXPERIENCED REFRACTORY HYPOXIA DUE TO FLASH PULMONARY EDEMA, PROMPTING CANNULATION FOR VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV-ECMO). AFTER RETURN OF SPONTANEOUS CIRCULATION, THE PATIENT REMAINED IN ATRIAL FIBRILLATION WITH COMPLETE HEART BLOCK WHICH PROMPTED THE PLACEMENT OF A SCREW-IN PACING LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574278 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention