BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONARY VALVE & CONDUIT SG

    MDR report key: 7642466 · Received June 27, 2018

    Report

    Report Number
    1063481-2018-00022
    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 GRAFT WAS NOT RETURNED TO CRYOLIFE SO NO DIRECT OBSERVATIONS WERE MADE. 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. LIMITED INFORMATION IS AVAILABLE REGARDING THE DETAILS OF THE EVENT, INCLUDING PATIENT DEMOGRAPHICS (AGE AT TIME OF IMPLANT, HEIGHT, AND WEIGHT), PRE-OPERATIVE DIAGNOSES, SPECIFIC PATIENT HISTORY, INDICATION FOR THE ROSS PROCEDURE, DATE WHEN THE GRAFT STENOSIS WAS FIRST NOTED FOLLOWING THE PROCEDURE, SEVERITY/GRADE OF PULMONARY STENOSIS, OPERATIVE NOTES, 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.¿ CURRENTLY, THE PATIENT IS BEING FOLLOWED MEDICALLY AND THERE ARE NO PLANS FOR REINTERVENTION OR GRAFT REPLACEMENT. 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). DUE TO THE LIMITED AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 PATIENT RECEIVED THE SGPV00 ON 11/06/2017. 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, THE PATIENT RECEIVED THE SGPV00 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
    484539 PULMONARY VALVE & CONDUIT SG HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT OHA CRYOLIFE, INC. SGPV00 143283

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O