BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONARY VALVE & CONDUIT SG

    MDR report key: 16400499 · Received February 17, 2023

    Report

    Report Number
    1063481-2023-00003
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    November 21, 2022
    Report Date
    April 21, 2023
    Manufacturer
    ARTIVION, INC.
    Product Code
    OHA
    PMA / PMN Number
    K092021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WILL BE FORTHCOMING AS PATIENT HAS DENIED CONSENT TO RELEASE INFORMATION TO ARTIVION. ACCORDING TO THE REPORTED INFORMATION THE ALLOGRAFT WAS IMPLANTED INTO A 41-YEAR-OLD MALE ON (B)(6) 2021 AS A PULMONARY VALVE PER THE IMPLANT SUMMARY CARD. DETAILS RELATED TO THIS IMPLANT PROCEDURE ARE UNAVAILABLE AT THIS TIME. PER THE ADDITIONAL INFORMATION RECEIVED, THIS ORIGINAL VALVE WAS EXPLANTED ON (B)(6) 2022, APPROXIMATELY 12 MONTHS POST-OPERATIVE DUE TO ENDOCARDITIS, HENCE A SIGNIFICANT TIME GAP IS NOTED BETWEEN IMPLANT AND THE DESCRIBED CLINICAL EVENT. A SGPV00 (PULMONARY VALVE & CONDUIT SG) WAS IMPLANTED DURING THIS SAME PROCEDURE. THE FILE FOR THIS DONOR WAS REVIEWED AND MET ALL CRITERIA FOR ALLOGRAFT PROCESSING AS WELL AS MEDICAL DIRECTOR REVIEW. THEREFORE, THE DONOR WAS FOUND TO BE ELIGIBLE FOR DONATION, AND THE TISSUE WAS RELEASED PER ALL PROCESSING CRITERIA. NO TISSUE WAS RETURNED FOR EVALUATION AND NO LABORATORY OR PATHOLOGY REPORTS HAVE BEEN PROVIDED TO CONFIRM THE REPORTED ENDOCARDITIS. OPERATIVE NOTES ARE NOT AVAILABLE FOR THE INCIDENT OR REOPERATION CURRENTLY AND NO ADDITIONAL INFORMATION IS PENDING. NO TISSUE WAS RETURNED FOR EVALUATION AND NO LABORATORY OR PATHOLOGY REPORTS HAVE BEEN PROVIDED. THE CARDIAC IFU LISTS ENDOCARDITIS AS A POTENTIAL COMPLICATION AND SHOULD BE CONSIDERED IN THE DECISION OF GRAFT SELECTION. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENTS AND ANY RELATION TO THE ALLOGRAFT/DONOR. THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED ENDOCARDITIS IS ASSOCIATED WITH THE ALLOGRAFT RELATED TO THIS PROCEDURE/PATIENT. ADEQUATE PRECAUTIONS ARE PROVIDED IN THE INSTRUCTIONS FOR USE. ADDITIONALLY, THE EXPLANTED TISSUE WAS NOT RETURNED TO ARTIVION, AND THEREFORE COULD NOT BE EXAMINED TO DETERMINE A ROOT CAUSE FOR THE REPORTED ENDOCARDITIS. GIVEN THAT ALL MICROBIOLOGICAL TESTING PERFORMED BY ARTIVION DURING PROCESSING PRODUCED ACCEPTABLE RESULTS, THE REPORTED EVENT MOST LIKELY REPRESENTS A CONTAMINATION OCCURRING AT THE IMPLANTING SITE. THE CURRENT CONTROLS IN PLACE ADEQUATELY MITIGATE RISK TO THE PATIENT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THIS GRAFT WAS EXPLANTED DUE TO ENDOCARDITIS. THIS GRAFT WAS IMPLANTED ON (B)(6) 2021 AND EXPLANTED ON (B)(6) 2022. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359966 PULMONARY VALVE & CONDUIT SG HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT OHA ARTIVION, INC. SGPV00 166433

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R