BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONARY VALVE & CONDUIT SG

    MDR report key: 7642487 · Received June 27, 2018

    Report

    Report Number
    1063481-2018-00023
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    September 19, 2018
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    OHA
    PMA / PMN Number
    K092021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROCESSING RECORDS FOR THE PRODUCT WERE REVIEWED AND IT WAS CONFIRMED THAT THE GRAFT DID NOT CONTAIN ANY ATTRIBUTES THAT WOULD HAVE REJECTED THE GRAFT. THE TECHNICIAN WHO INSPECTED THIS GRAFT WAS APPROPRIATELY TRAINED. THE INSPECTOR NOTED FIBROUS THICKENING OF ALL LEAFLETS AND AT THE ANNULUS OF ALL LEAFLETS. THE GRAFT WAS RETURNED PARTIALLY INTACT AND PART OF THE CONDUIT AND THE BIFURCATION HAD BEEN TRANSECTED AWAY FROM THE VALVE. THE SAMPLE WAS RETURNED IN FORMALIN AND COULD BE PART OF THE REASON THE TISSUE WAS HARD AND THE CONDUIT APPEARED THICKENED. NON-CRYOLIFE SUTURES WERE OBSERVED IN THE MUSCLE BAND. ALL THREE LEAFLETS WERE ATTACHED AND APPEARED TO BE ACCEPTABLE. THERE IS LIMITED INFORMATION AVAILABLE RELATED TO THE STENOSIS AND EXPLANT OF THE PRODUCT, DESPITE REQUESTS FOR ADDITIONAL INFORMATION RELATED TO THE EVENT, INCLUDING OPERATIVE NOTES, 6 MONTH POSTOPERATIVE SCANS, PERTINENT PATIENT CO-MORBIDITIES/PAST MEDICAL HISTORY, INDICATION FOR THE ORIGINAL ROSS PROCEDURE, AND PATIENT MEDICAL HISTORY. THE SURGEON WAS CONCERNED THAT HIS STAFF (WHICH INCLUDES SEVERAL NEW RNS) MAY HAVE THAWED THE GRAFT TOO QUICKLY AND DID NOT FOLLOW THE PROPER THAW AND RINSE PROTOCOL, AND FELT THAT THIS COULD HAVE ATTRIBUTED TO GRAFT STENOSIS. THE SURGEON ALSO NOTED ¿FRIABLE HOST TISSUE (PATIENT¿S) REQUIRING MULTIPLE REPAIR STITCHES.¿ THE PATHOLOGY EXAMINATION OF THE EXPLANTED VALVE NOTED DENSE PERIVALVULAR FIBROSIS WITH MINIMAL INFLAMMATION, FOCAL EROSION OF THE VALVE LEAFLETS, AND LEAFLET REDUNDANCY. ACCORDING TO BROWN ET AL., APPROXIMATELY 20% OF ROSS PATIENTS WHO RECEIVED AN SGPV PRESENTED WITH MEAN PULMONARY GRADIENTS OF = 30 MM HG AT 4 YEARS OF FOLLOW-UP (BROWN 2010). THE VALVULAR STENOSIS WAS A RESULT OF THE PERIVALVULAR FIBROSIS; HOWEVER, THE ETIOLOGY OF THE EXTENSIVE FIBROTIC REACTION IS UNKNOWN. IT IS POSSIBLE THAT THE ADDITIONAL SUTURING REQUIRED MAY HAVE CONTRIBUTED TO THE EVENT. 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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORT, THE PRODUCT WAS IMPLANTED ON (B)(6) 2017. THE PATIENT'S 6-MONTH POST OPERATIVE SCAN INDICATED PULMONARY VALVE CONDUIT STENOSIS

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, SGPV00 WAS IMPLANTED ON (B)(6) 2017. THE PATIENT'S 6-MONTH POST OPERATIVE SCAN INDICATED PULMONARY VALVE CONDUIT STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484943 PULMONARY VALVE & CONDUIT SG HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT OHA CRYOLIFE, INC. SGPV00 145631

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O