BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONARY VALVE & CONDUIT

    MDR report key: 20055200 · Received August 23, 2024

    Report

    Report Number
    1063481-2024-00020
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    May 29, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ARTIVION, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 0

    THE CERTIFICATE OF ASSURANCE FOR PULMONARY VALVE & CONDUIT (PV00) 7791789 WAS REVIEWED. ALL ATTRIBUTES IDENTIFIED DURING INSPECTION WERE DOCUMENTED APPROPRIATELY ON THE CERTIFICATE OF ASSURANCE. NO REJECTABLE ATTRIBUTES WERE NOTED. BASED ON THE PERFORMANCE OF THE TISSUE, THERE IS NO INDICATION THAT THERE WAS ANY DEFICIENCY IN THE VALVE. DURING THE INSPECTION OF EACH GRAFT, A QUALIFIED INSPECTOR WEARING SURGICAL LOUPES INSPECTS THE GRAFT NOTING ANY ATTRIBUTES. BASED ON A REVIEW OF ARCHIVED TRAINING RECORDS, THE INSPECTOR WAS FOUND TO BE APPROPRIATELY TRAINED AT THE TIME THE TASK WAS PERFORMED. NO FINDINGS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTION IS NEEDED. THERE IS LIMITED INFORMATION AVAILABLE REGARDING THE EVENT, INCLUDING BUT NOT LIMITED TO PREOPERATIVE DIAGNOSES, PAST MEDICAL HISTORY, OR THE REASON FOR THE REPORTED EXPLANT 22 YEARS POST-OPERATIVE. NO OPERATIVE NOTES ARE AVAILABLE AT THIS TIME AND NO EXPLANTED TISSUE WAS RETURNED FOR EVALUATION. PER THE IMPLANT SUMMARY DATABASE, THIS PV00 WAS IMPLANTED ON (B)(6) 2002 IN A 5.5-YEAR-OLD FEMALE AS A "PULMONARY VALVE". PER THE IMPLANT CARD RECEIVED, THIS VALVE WAS EXPLANTED ON (B)(6) 2024 AND A SGPV00 WAS IMPLANTED DURING THE SAME PROCEDURE. THERE ARE NO ADDITIONAL DETAILS AVAILABLE FOR THE TIME FRAME BETWEEN THE ORIGINAL IMPLANT IN 2002 AND THE PROCEDURE PERFORMED IN 2024. HOMOGRAFTS REMAIN ONE OF MOST USED MATERIALS FOR PEDIATRIC CARDIAC RECONSTRUCTION PROCEDURES, DESPITE THE LIKELY NEED FOR FUTURE REOPERATION (BIELEFELD 2001). THE CRYOVALVE® INSTRUCTIONS FOR USE (IFU) LIST ADVERSE EVENTS REPORTED WITH THE USE OF CARDIAC ALLOGRAFTS, INCLUDING NORMAL VALVE OUTGROWTH. NO TISSUE SAMPLE WAS RETURNED FOR EVALUATION AND THERE IS INSUFFICIENT INFORMATION TO DETERMINE A ROOT CAUSE OF THE REPORTED EXPLANT 22 YEARS POST-OPERATIVE. REOPERATION IN THIS PEDIATRIC POPULATION IS NOT AN UNEXPECTED OUTCOME AS REPORTED IN THE LITERATURE. ADEQUATE PRECAUTIONS ARE PROVIDED IN THE INSTRUCTIONS FOR USE. EXPLANT OF A CARDIAC HOMOGRAFT AFTER 22 YEARS NOT UNEXPECTED. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE IMPLANT SUMMARY CARD RECEIVED, AN EXPLANT OF A PREVIOUSLY IMPLANTED GRAFT WAS MARKED TO HAVE OCCURRED ON (B)(6) 2024. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITH NO RESPONSE, THEREFORE THIS EVENT WILL BE INVESTIGATED AS AN UNKNOWN EXPLANT. ACCORDING TO OUR IMPLANT DATABASE, THIS PATIENT WAS IMPLANTED WITH THIS GRAFT ON (B)(6) 2002.

    Description of Event or Problem · 0

    ACCORDING TO THE IMPLANT SUMMARY CARD RECEIVED, AN EXPLANT OF A PREVIOUSLY IMPLANTED GRAFT WAS MARKED TO HAVE OCCURRED ON (B)(6) 2024. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITH NO RESPONSE, THEREFORE THIS EVENT WILL BE INVESTIGATED AS AN UNKNOWN EXPLANT. ACCORDING TO OUR IMPLANT DATABASE, THIS PATIENT WAS IMPLANTED WITH THIS GRAFT ON (B)(6) 2002.

    Description of Event or Problem · 0

    ACCORDING TO THE IMPLANT SUMMARY CARD RECEIVED, AN EXPLANT OF A PREVIOUSLY IMPLANTED GRAFT WAS MARKED TO HAVE OCCURRED ON (B)(6) 2024. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITH NO RESPONSE, THEREFORE, THIS EVENT WILL BE INVESTIGATED AS AN UNKNOWN EXPLANT. ACCORDING TO OUR IMPLANT DATABASE, THIS PATIENT WAS IMPLANTED WITH THIS GRAFT ON (B)(6) 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527732 PULMONARY VALVE & CONDUIT HEART-VALVE, ALLOGRAFT MIE ARTIVION, INC. PV00 59757

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention| H