BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 19666758 · Received July 3, 2024

    Report

    Report Number
    2015691-2024-05077
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    UDI-DI
    00690103176131
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, G3, G6, H2, H6 (INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED, AS NO INFORMATION REGARDING A DEVICE FAILURE MODE WAS PROVIDED. FURTHERMORE, 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 DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR (B)(4). ENGINEERING EVALUATION SUMMARY: THE COMPLAINT INVESTIGATION WAS CONDUCTED, USING EVALUATION SUMMARY DOC-0212705 AND TRIAGE LEVEL 1, IN ACCORDANCE WITH TCA (B)(4) REV. E DUE DILIGENCE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING A DEVICE FAILURE MODE, HOWEVER ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME. PATIENT MEDICAL RECORDS WERE NOT PROVIDED BY THE HOSPITAL FOR REVIEW, OR THE MEDICAL RECORDS PROVIDED DO NOT CLARIFY THE DEVICE FAILURE MODE. PER THE INSTRUCTIONS FOR USE (IFU), REOPERATION/EXPLANT ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC CARDIAC VALVES AND ANNULOPLASTY RINGS. IN THIS CASE, THERE IS NO EVIDENCE 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT (PRA) NOR CORRECTIVE OR PREVENTIVE ACTIONS (CAPA/SCAR) ARE REQUIRED AT THIS TIME, PER (B)(4). BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. ALL PERTINENT INFORMATION AVAILABLE TO EDWARDS LIFESCIENCES HAS BEEN SUBMITTED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 21MM 3300TFX AORTIC VALVE IN AORTIC POSITION IS UNDER EVALUATION FOR A POSSIBLE VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 7 MONTHS DUE TO UNKNOWN REASONS. TAVR HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760403 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 3300TFX N/A 00690103176131

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Life Threatening| O