BEUDAMED
    FDA Adverse Event Death Summary report: Y

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 11100272 · Received December 31, 2020

    Report

    Report Number
    3005619880-2020-00110
    Event Type
    Death
    Date Received
    December 31, 2020
    Date of Event
    June 7, 2018
    Report Date
    April 6, 2021
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AZIYO BIOLOGICS WOULD LIKE TO AMEND/CORRECT THE FOLLOWING DATA FIELDS OF THIS MDR REPORT PER NOTIFICATION FROM FDA MDR TEAM OF INCORRECT USAGE OF BOX H.1 - SUMMARY REPORT AND CORRESPONDING NO. OF EVENTS SUMMARIZED: FIELDS TO BE CORRECTED (FROM/TO): BOX B.3 --- FROM: BLANK (NO DATE PROVIDED), TO: 06/07/2018. REASON: ADDITIONAL SUMMARY INFORMATION REQUESTED PER MDR REPORTING GUIDANCE DOCUMENT SECTION 4.16.2. BOX G.2 --- FROM: FOREIGN, STUDY, AND LITERATURE SELECTED, TO: LITERATURE (ONLY SELECTED). REASON: AZIYO BECAME AWARE OF THE FOREIGN STUDY VIA THE PUBLISHED LITERATURE ONLY. BOX H.5 ----FROM: ARTICLE SUMMARY (KEEP AS IS), TO: ARTICLE SUMMARY AMENDED TO ADD: THIS MDR IS ONE (1) OF TWO (2) MDRS SUBMITTED FOR THIS PUBLISHED LITERATURE. THIS MDR SUMMARIZES THE EVENTS SURROUNDING A TOTAL OF THREE (3) REPORTED DEATHS. SUMMARY DATA REGARDING THE 44 PATIENTS IN THIS RESTROSPECTIVE REVIEW HAD AN AVERAGE AGE OF 10.9 DAYS +/- 18.8 DAYS (RANGE FROM 3 DAYS TO 128 DAYS). A TOTAL OF 64% OF PATIENTS HAD HYPOPLASTIC LEFT HEART SYNDROME (HLHS), 16% HAD DOUBLE INLET LEFT VENTRICLE, 9% WITH TRICUSPID ATRESIA, 9% WITH UNBALANCED AVSD, AND 2% WITH DOUBLE OUTLET RIGHT VENTRICLE. MALES REPRESENTED THE MAJORITY OF PATIENTS (68%), WITH AN AVERAGE WEIGHT OF 3.28 KG+/- 0.65 KG (1.52 - 4.32). REASON: ADDITIONAL SUMMARY INFORMATION REQUESTED PER MDR REPORTING GUIDANCE DOCUMENT SECTION 4.16.2. BOX H.1 - FROM: SELECTION OF DEATH AND SUMMARY REPORT WITH 3 EVENTS SUMMARIZED TO: DEATH SELECTED ONLY (DE-SELECT SUMMARY REPORT AND NO. EVENTS SUMMARIZED) REASON: NOTIFICATION FROM FDA MDR TEAM OF IMPROPER USE OF SUMMARY REPORT BOX - SUBMISSION NOT INTENDED TO BE REPORTED VIA VMSR PROGRAM. BOX H.6 - FROM: HEALTH EFFECT - CLINICAL CODE: 4580, TO: REMOVE CODE; BOX H.6 - FROM: HEALTH EFFECT - IMPACT CODE: 1802, TO: REMOVE CODE; BOX H.6 - FROM: MEDICAL DEVICE PROBLEM CODE: 2993, TO: REMOVE CODE; BOX H.6 - FROM: COMPONENT CODE: 4755, TO: REMOVE CODE; BOX H.6 - FROM: TYPE OF INVESTIGATION: 4117, TO: REMOVE CODE; BOX H.6 - FROM: INVESTIGATION FINDINGS: 3221, TO: REMOVE CODE; BOX H.6 - FROM: INVESTIGATION CONCLUSIONS: 4315, TO: REMOVE CODE. REASON: PER MEDICAL DEVICE REPORTING FOR MANFACTURERS GUIDANCE FOR INDUSTRY, SECTION 4.16 - REPORTS BASED ON LITERATURE, SPECIFICALLY SECTION 4.16.2 (BULLET POINT #4 - PG. 36) AN EXCEL SPREADSHEET IS PROVIDED AS AN ATTACHED DOCUMENT PROVIDING ALL REPORTING CODES FOR EACH OF THE 3 REPORTED DEATHS).

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR DEVICE HISTORY RECORD(S) COULD NOT BE COMPLETED AS THE LOT/SERIAL NUMBER(S) WERE NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED IN THE PUBLISHED LITERATURE RELATING TO THESE EVENTS AND ATTEMPTS TO CONTACT CORRESPONDING AUTHOR HAVE BEEN UNSUCESSFUL AT THE TIME OF THIS REPORT. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THESE EVENTS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS SINGLE CENTER, SINGLE SURGEON RETROSPECTIVE CLINICAL REVIEW OF NORWOOD PALLIATION PROCEDURES PUBLISHED IN THE ANNALS OF THORACIC SURGERY TITLED "PORCINE SMALL INTESTINAL SUBMUCOSA MAY BE A SUITABLE MATERIAL FOR NORWOOD ARCH RECONSTRUCTION" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF FORTY-FOUR (44) PEDIATRIC PATIENTS WITH SINGLE-VENTRICLE ANATOMY UNDERGOING A NORWOOD PALLIATION WITH INTERDIGITATING ARCH RECONSTRUCTION USING A PORCINE SMALL INTESTINAL SUBMUCOSA (PSIS) EXTRACELLULAR MATRIX FROM CORMATRIX CARDIOVASCULAR, NOW AZIYO BIOLOGICS. THE SPECIFIC MATERIAL IS NOT REFERENCED, BUT CORMATRIX ECM FOR CARDIAC TISSUE REPAIR WOULD BE INDICATED FOR THESE TYPES OF HEART REPAIR. THE REVIEW SPANNED THE PERIOD OF 2/2011 THROUGH 1/2015. THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR WAS UTILIZED TO COMPLETE THE CONSTRUCTION OF THE NEOAORTA AND THE SYSTEMIC TO PULMONARY ARTERY SHUNT. IN ADDITION THE ECM WAS USED FOR THE DISTAL MAIN PULMONARY ARTERY PATCH. THE CONDUCTED REVIEW OF THIS STUDY COHORT DEFINED REINTERVENTIONS AS THOSE SPECIFIC TO THE RECONSTRUCTED NEOAORTIC ARCH AND MONITORED PATIENT "INTERSTAGE" SURVIVAL. AS THE NORWOOD PROCEDURE IS THE INITIAL PALLIATION FOR HYPOPLASTIC LEFT HEART SYNDROME (HLHS) PROVIDING SURVIVABILITY TO THE SECOND PHASE (BI-DIRECTIONAL GLENN (BDG) PROCEDURE), AND FINALLY TO THE FONTAN PROCEDURE AND/OR HEART TRANSPLANT; REINTERVENTION IN THIS STUDY WAS DEFINED AS INTERVENTION WITHIN THE "INTERSTAGE" PERIOD. OF THE FORTY-FOUR (44) PATIENTS REVIEWED, THERE WERE THREE (3) PATIENT DEATHS. NO SPECIFIC DETAILS ARE PROVIDED REGARDING EITHER OF THE REPORTED DEATHS ASIDE FROM THE STATEMENT THAT "ONE PATIENT DIED EARLY AFTER NORWOOD PALLIATION, AND 2 PATIENTS DIED LATE, WITH ONE DYING AFTER BDG". NO OTHER DETAILS WERE PROVIDED. ATTEMPTS TO CONTACT THE CORRESPONDING AUTHOR HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS FILING FOR ADDITIONAL INFORMATION 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
    1567094 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death