BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 11091692 · Received December 29, 2020

    Report

    Report Number
    3005619880-2020-00085
    Event Type
    Death
    Date Received
    December 29, 2020
    Report Date
    December 29, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED. IT IS NOTED THAT THE REPORTED COMPLICATION OF PULMONARY HYPERTENSION AND RESPIRATORY FAILURE ARE LIKELY COMPLICATIONS ASSOCIATED WITH THE PROCEDURE AND/OR DEVELOPMENT OF THE PATIENT LUNGS AND PREMATURE BIRTH. NO FURTHER DETAILS WERE PROVIDED IN THE PUBLISHED LITERATURE RELATING TO THIS EVENT AND ATTEMPTS TO CONTACT CORRESPONDING AUTHOR HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS SINGLE CENTER RETROSPECTIVE CLINICAL REVIEW PUBLISHED IN CONGENITAL HEART DISEASE TITLED "COMPLETE ATRIOVENTRICULAR CANAL REPAIR WITH A DECELLULARIZED PORCINE SMALL INTESTINAL SUBMUCOSA PATCH" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF SEVENTY-THREE (73) PEDIATRIC PATIENTS TREATED FOR COMPLETE ATRIOVENTRICULAR CANAL REPAIR USING EITHER A TWO-PATCH TECHNIQUE WITH CORMATRIX ECM FOR CARDIAC TISSUE REPAIR OR A MODIFIED SINGLE PATCH "AUSTRALIAN" REPAIR. FOR THE TWO-PATCH TECHNIQUE, THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR WAS USED PRIMARILY FOR VENTRICULAR SEPTAL DEFECT REPAIR (VSD) WHILE AUTOLOGOUS PERICARDIUM WAS USED FOR ATRIAL SEPTAL DEFECT (ASD) REPAIR. FOR THE MODIFIED SINGLE-PATCH TECHNIQUE, CORMATRIX ECM FOR CARDIAC TISSUE REPAIR WAS USED IN 15 OF 21 CASES. FIFTY-TWO (52) PATIENTS WERE TREATED USING THE TWO-PATCH REPAIR WHILE ANOTHER TWENTY-ONE (21) PATIENTS WERE TREATED WITH THE MODIFIED AUSTRALIAN REPAIR. OF THESE PATIENTS, THE ARTICLE STATES THAT THERE WAS ONE (1) PATIENT DEATH OCCURRING IN THIS STUDY. THIS RETROSPECTIVE REVIEW EVALUATED PATIENT PROCEDURES CONDUCTED BETWEEN 3/2010 AND 9/2017. THE REPORTED PATIENT DEATH INVOLVED A (B)(6) PREMATURE INFANT AND TREATED WHO NEVER LEFT THE NEONATAL ICU PREOPERATIVELY AND HAD A COMPLETE ATRIOVENTRICULAR CANAL (CAVC) AND LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION (LVOTO) REPAIR AT THE AGE OF 3 MONTHS. THE PATIENT DIED OF RESPIRATORY FAILURE IN SETTING OF PULMONARY HYPERTENSION TWO MONTHS POST-OP WITH EVIDENCE OF GOOD CARDIAC REPAIR ON TRANSTHORACIC ECHOCARDIOGRAPHY. THE ARTICLE PROVIDED NO DETAILS AS TO TREATMENT TECHNIQUE USED FOR THIS PATIENT AND WHETHER ONLY CORMATRIX ECM FOR CARDIAC TISSUE REPAIR, AUTOLOGOUS PERICARDIUM, OR COMBINATION OF BOTH PRODUCTS WERE USED IN THIS PROCEDURE. ATTEMPTS TO CONTACT THE CORRESPONDING AUTHOR HAVE BEEN UNSUCCESSFUL AT TIME OF THIS REPORT REGARDING SPECIFIC PRODUCT USED AND CORRESPONDING LOT NUMBERS. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550189 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Death