BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SAPIEN VALVE

    MDR report key: 12594648 · Received October 7, 2021

    Report

    Report Number
    2015691-2021-05552
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    January 1, 2015
    Report Date
    December 7, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT TO RELATED NUMBER. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691- 2021- 05553.

    Additional Manufacturer Narrative · 0

    AN ADMINISTRATIVE REVIEW OF 3500A FORMS POSTED ON THE MAUDE DATABASE SHOWED THIS MANUFACTURER REPORT WAS SUBMITTED WITH THE INCORRECT COMMON DEVICE NAME AND PRODUCT CODE. A CORRECTION TO FIELDS D2 IS BEING SUBMITTED IN THIS SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE STATUS OF THE DEVICE IS UNKNOWN. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM TO JANUARY 2015 AND MARCH 2020. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-JANUARY-2015) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT DELIVERY SYSTEM MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS DELIVERY SYSTEM. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS DELIVERY SYSTEM: P130009 - EDWARDS COMMANDER DELIVERY SYSTEM WITH SAPIEN XT AND P140031 FOR SAPIEN 3 OR P200015 FOR SAPIEN 3 WITH COMMANDER FOR PULMONIC INDICATION 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 THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION AND EMBOLIZATION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE MALPOSITION/EMBOLIZATION, INCLUDING, BUT NOT LIMITED TO, IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, LOSS OF PACING CAPTURE, RAPID DEPLOYMENT AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THE SAPIEN 3 VALVE IN A DILATED NATIVE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) IS NOT INDICATED PER THE LABELING; THEREFORE THE LABELING (IFUS AND EW TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE SAPIEN 3 VALVE IN THIS SCENARIO. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS ARE INCONCLUSIVE AS LIMITED INFORMATION WAS PROVIDED IN THE ARTICLE. 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. ARTICLE REFERENCE: GUZELTAS A, TANIDIR IC, GOKALP S, TOPKARCI MA, SAHIN M, ERGUL Y. IMPLANTATION OF THE EDWARDS SAPIEN XT AND SAPIEN 3 VALVES FOR PULMONARY POSITION IN ENLARGED NATIVE RIGHT VENTRICULAR OUTFLOW TRACT. ANATOL J CARDIOL. 2021 FEB;25(2):96-103. DOI: 10.14744/ANATOLJCARDIOL.2020.46024. PMID: 33583816; PMCID: PMC8114652.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN TURKEY, THROUGH THE REVIEW OF THE MEDICAL ARTICLE: ''IMPLANTATION OF THE EDWARDS SAPIEN XT AND SAPIEN 3 VALVES FOR PULMONARY POSITION IN ENLARGED NATIVE RIGHT VENTRICULAR OUTFLOW TRACT'', CORRESPONDING AUTHOR ALPER GUZELTAS, THE FOLLOWING EVENTS WERE IDENTIFIED: AFTER PERCUTANEOUS PULMONARY VALVE IMPLANTATION WITH SAPIEN XT OR SAPIEN S3 VALVES IN PATIENTS WITH DILATED NATIVE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT): IN 1 PATIENT, THE VALVE WAS EMBOLIZED BACK TO THE RVOT DURING VALVE OPENING AND THEREFORE COULD NOT BE FURTHER ADVANCED, MAKING HIM UNDERGO URGENT SURGICAL PVI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486720 UNKNOWN SAPIEN VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN
    1486725 UNKNOWN SAPIEN VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention