BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOPATCH SG PULMONARY TRUNK

    MDR report key: 8503386 · Received April 11, 2019

    Report

    Report Number
    1063481-2019-00018
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 12, 2019
    Report Date
    July 29, 2019
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K110581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO INFORMATION FROM THE CRYOLIFE IMPLANT DATABASE, THE CRYOPATCH SG PULMONARY TRUNK PATCH WAS IMPLANTED IN A 5-DAY OLD FEMALE NEONATE DURING A NORWOOD PROCEDURE ON (B)(6) 2018. THE PATIENT UNDERWENT A PLANNED/STAGED GLENN PROCEDURE ON (B)(6) 2019, AT WHICH TIME IT WAS ALLEGED THAT THE PATCH USED DURING THE NORWOOD PROCEDURE 4 MONTHS PRIOR ¿LOOKED CALCIFIED¿. THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING PATIENT DEMOGRAPHICS, PERTINENT MEDICAL HISTORY, PRE-OPERATIVE DIAGNOSES, HOW THE SG PATCH WAS USED IN THE NORWOOD PROCEDURE, THE DEGREE OF CALCIFICATION PRESENT, WHETHER THE CALCIFICATION WAS NOTED PRIOR TO THE PATIENT UNDERGOING THE PLANNED/STAGED GLENN PROCEDURE, OR IF THE ALLEGED CALCIFICATION WAS CAUSING ANY ISSUES RELATED TO CARDIAC FUNCTION OR PERFORMANCE. IN ADDITION, NONE OF THE ALLEGED CALCIFIED PATCH MATERIAL WAS EXPLANTED OR SUBMITTED FOR HISTOLOGY/PATHOLOGY AT THE IMPLANTING HOSPITAL OR PROVIDED TO CRYOLIFE FOR HISTOLOGICAL ANALYSIS. THE NORWOOD PROCEDURE IS THE FIRST STAGE OF A 3-PART SURGICAL PALLIATION PROCEDURE TO CORRECT HYPOPLASTIC LEFT HEART SYNDROME (HLHS). HYPOPLASTIC LEFT HEART SYNDROME (HLHS) CONSTITUTES A SPECTRUM OF CARDIAC ANOMALIES THAT RESULT IN UNDERDEVELOPMENT OF LEFT-SIDED HEART STRUCTURES. IT IS CHARACTERIZED BY UNDERDEVELOPMENT OF THE AORTA, AORTIC VALVE, LEFT VENTRICLE, MITRAL VALVE, AND LEFT ATRIUM, RESULTING IN SEVERE OR TOTAL OBSTRUCTION OF BLOOD FLOW FROM THE LEFT VENTRICLE (SIVANANDAM 2011). COARCTATION OF THE AORTA (NARROWING OF THE AORTA) IS THE MOST FREQUENTLY ASSOCIATED ANOMALY WITH HLHS AND WITHOUT SOME FORM OF INTERVENTION, HLHS IS UNIVERSALLY FATAL WITHIN THE FIRST WEEKS OF LIFE AND IS THE MOST COMMON CAUSE OF CARDIAC-RELATED DEATH IN CHILDREN LESS THAN ONE MONTH OF AGE (ATIK 2006). THE GOALS OF NORWOOD PROCEDURE ARE TO RELIEVE SYSTEMIC OUTFLOW TRACT OBSTRUCTION, PROVIDE NONRESTRICTIVE CORONARY BLOOD FLOW AND ADEQUATE PULMONARY BLOOD FLOW, AND CREATE A NONRESTRICTIVE ATRIAL SEPTAL DEFECT (FEINSTEIN 2012). THE NORWOOD PALLIATION OF HLHS INCLUDES CONSTRUCTING A NEO-AORTA UTILIZING THE PULMONARY ROOT, ASCENDING AORTA, AND CRYOPRESERVED HOMOGRAFT TISSUE (THE PATCH MATERIAL). THE DUCTAL TISSUE IS RESECTED AND THE AUGMENTATION OF THE AORTIC ARCH AND SITE OF COARCTATION IS CARRIED OUT. PULMONARY BLOOD FLOW IS PROVIDED BY PLACEMENT OF A SHUNT. THE NORWOOD PROCEDURE IS PERFORMED SHORTLY AFTER BIRTH WITHIN THE FIRST WEEK OF LIFE. THE SECOND PROCEDURE, KNOWN AS THE BI-DIRECTIONAL GLENN OR HEMI-FONTAN, IS PERFORMED BETWEEN 3-6 MONTHS OF AGE, AND THE FINAL STAGE, KNOWN AS THE FONTAN, BETWEEN 18 MONTHS-5 YEARS OF AGE. CRYOPATCH SG IS INDICATED FOR REPAIR OR RECONSTRUCTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT; HOWEVER, IT IS UNKNOWN HOW THE CRYOPATCH SG WAS USED DURING THE NORWOOD PROCEDURE. CALCIFICATION IS INCLUDED IN THE IFU (INSTRUCTIONS FOR USE) AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF CRYOPATCH SG. IN ADDITION, THE PATCH WAS LEFT IMPLANTED WHICH INDICATES THAT THE CALCIFICATION DID NOT SIGNIFICANTLY IMPACT HEMODYNAMICS. ALL RISKS IDENTIFIED HAVE BEEN MITIGATED AS FAR AS POSSIBLE AND 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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "[COMPLAINANT] CALLED ME TODAY AND SAID THAT OVER THE WEEKEND THEY HAD A REDO GLEN PROCEDURE. DURING THE CASE THEY MENTIONED THAT A PATCH USED ON THIS PATIENT FOR A NORWOOD PROCEDURE ON (B)(6) 2018 LOOKED CALCIFIED."

    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 INITIAL REPORT, "[COMPLAINANT] CALLED ME TODAY AND SAID THAT OVER THE WEEKEND THEY HAD A REDO GLEN PROCEDURE. DURING THE CASE THEY MENTIONED THAT A PATCH USED ON THIS PATIENT FOR A NORWOOD PROCEDURE ON (B)(6) 2018 LOOKED CALCIFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295825 CRYOPATCH SG PULMONARY TRUNK PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ CRYOLIFE, INC. SGP010 147286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other