BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 20428383 · Received October 11, 2024

    Report

    Report Number
    2015691-2024-07765
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 17, 2024
    Report Date
    November 13, 2024
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    UDI-DI
    00690103186253
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: 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.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). 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. ENGINEERING EVALUATION SUMMARY: PER TECHNICAL SUMMARY DOC-0221939, REV B, CALCIFIC DEGENERATION INVOLVES THE GRADUAL ACCUMULATION OF CALCIUM DEPOSITS ON THE VALVE LEAFLETS. IT IS A DISEASE CONTINUUM FROM SCLEROSIS TO CHRONIC INFLAMMATION THAT LEADS TO LEAFLET CALCIFICATION. THESE CALCIUM DEPOSITS, OVER TIME, CAUSE THE LEAFLETS TO BECOME RIGID AND LESS FLEXIBLE, WHICH CAN ACCOUNT FOR FAILURE MODES SUCH AS STENOSIS AND REGURGITATION. SVD IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BHV IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. PER DOC-0101337, REV P, AN ENGINEERING EVALUATION IS NOT REQUIRED BECAUSE THERE IS NO ALLEGATION OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE AND/OR ONE WAS NOT SUSPECTED OR CONFIRMED THROUGH INVESTIGATION; NO LABELING NON-CONFORMANCE/DEFICIENCY; NO USE-RELATED ISSUE WITH A HAZARDOUS SITUATION; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. PER DOC-0101337, REV P, AND DOC-0076862, REV O, A CAPA/SCAR/PRA IS NOT REQUIRED, AS THERE ARE NO CONFIRMED PRODUCT OR LABELING NON-CONFORMANCE'S, AND NO OTHER TRIGGERS ARE MET. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CAUSED OR CONTRIBUTED. ALL PERTINENT INFORMATION AVAILABLE TO EDWARDS LIFESCIENCES HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    H11: CORRECTIVE DATA: BASED ON THE ADDITIONAL INFORMATION OBTAINED, THE FOLLOWING SECTIONS ARE UPDATED: B4, G3, G6, H2, H6 (INVESTIGATION CONCLUSIONS), AND THIS CORRECTION IS BEING SUBMITTED. ENGINEERING EVALUATION SUMMARY: PER TECHNICAL SUMMARY DOC-0221939, REV B, CALCIFIC DEGENERATION INVOLVES THE GRADUAL ACCUMULATION OF CALCIUM DEPOSITS ON THE VALVE LEAFLETS. IT IS A DISEASE CONTINUUM FROM SCLEROSIS TO CHRONIC INFLAMMATION THAT LEADS TO LEAFLET CALCIFICATION. THESE CALCIUM DEPOSITS, OVER TIME, CAUSE THE LEAFLETS TO BECOME RIGID AND LESS FLEXIBLE, WHICH CAN ACCOUNT FOR FAILURE MODES SUCH AS STENOSIS AND REGURGITATION. SVD IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BHV IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. PER DOC-0101337, REV P, AN ENGINEERING EVALUATION IS NOT REQUIRED BECAUSE THERE IS NO ALLEGATION OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE AND/OR ONE WAS NOT SUSPECTED OR CONFIRMED THROUGH INVESTIGATION; NO LABELING NON-CONFORMANCE/DEFICIENCY; NO USE-RELATED ISSUE WITH A HAZARDOUS SITUATION; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED, AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. PER DOC-0101337, REV P, AND DOC-0076862, REV O, A CAPA/SCAR/PRA IS NOT REQUIRED, AS THERE ARE NO CONFIRMED PRODUCT OR LABELING NON-CONFORMANCE'S, AND NO OTHER TRIGGERS ARE MET. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING HYPERLIPIDEMIA, METABOLIC SYNDROME, CORONARY ARTERY DISEASE AND ATHEROSCLEROSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 25MM 7300TFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO CALCIFICATION. TMVR WAS COMPLETED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 25MM 7300TFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO CALCIFICATION. PATIENT PRESENTED WITH HEART FAILURE WITH DYSPNEA. TMVR WAS COMPLETED WITH A 26MM 9750TFX TRANSCATHETER VALVE AND PATIENT WAS STABLE AND DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345895 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 7300TFX N/A 00690103186253

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| L| R