BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 19326543 · Received May 15, 2024

    Report

    Report Number
    2015691-2024-03619
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 10, 2024
    Report Date
    June 28, 2024
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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. TECHNICAL SUMMARY REFERENCE: THE COMPLAINT INVESTIGATION WAS CONDUCTED, USING EVALUATION SUMMARY DOC-0212705 AND TRIAGE LEVEL 1, IN ACCORDANCE WITH TCA DOC-0226303 REV. D. 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 DOC-0101337 AND DOC-0076862. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. ALL PERTINENT INFORMATION AVAILABLE TO EDWARDS LIFESCIENCES HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 3300TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, 10 MONTHS DUE TO UNKNOWN REASON. AVR WAS COMPLETED WITH A 25MM 11060A KONECT AORTIC VALVED CONDUIT. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649651 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 3300TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Life Threatening| R| H