BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H11

    MDR report key: 21480550 · Received February 27, 2025

    Report

    Report Number
    2015691-2025-01375
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 2, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). REGURGITATION IDENTIFIED POST-PROCEDURALLY HAS MANY POTENTIAL ROOT CAUSES, INCLUDING STRUCTURAL VALVE DETERIORATION (SVD), NON-STRUCTURAL VALVE DYSFUNCTION (NSVD), ENDOCARDITIS AND/OR THROMBOSIS. REGURGITATION OCCURRING DURING DEVICE IMPLANTATION OR POST-PROCEDURALLY IS MOST COMMONLY RELATED TO PATIENT AND/OR PROCEDURAL FACTORS AND IS NOT TYPICALLY AN INDICATION OF A DEVICE MALFUNCTION RELATED TO A MANUFACTURING NON-CONFORMANCE. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, HOWEVER, PATIENT FACTORS LIKELY CAUSED OR CONTRIBUTED TO THE COMPLAINT EVENT. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED, AND NO INADEQUACIES HAVE BEEN IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICES: MODEL #3300TFX AND 11500A; BRAND NAMES: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS AND INSPIRIS RESILIA AORTIC VALVE; PMAS #P860057 AND P150048. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 25MM 11000A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY SEVEN (7) YEARS, ONE (1) MONTH DUE TO MODERATE REGURGITATION. THE PATIENT WAS ASYMPTOMATIC 'APART FROM CHEST PAIN THAT WAS FELT TO BE NON-CARDIAC.' THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE WITH SURGICAL VALVE FRACTURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122733 SEE H11 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 11000A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Life Threatening| H| R