BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXICOR FOR CARDIAC TISSUE REPAIR

    MDR report key: 9664341 · Received February 4, 2020

    Report

    Report Number
    3005619880-2020-00001
    Event Type
    Death
    Date Received
    February 4, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 4, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED ON 11/27/2019 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING PRODUCTION AND FINAL PACKAGING. THE OEM SUPPLIER REVIEWED THE SUB-LOTS ASSOCIATED WITH THE REPORTED LOT AND CONFIRMED THAT "ALL DEVICES MET SPECIFICATION." THE INSTRUCTIONS FOR USE PROVIDED WITH THE PROXICOR FOR CARDIAC TISSUE REPAIR PRODUCT (ART-20700B), UNDER THE SECTION 'POTENTIAL COMPLICATIONS', STATES IN PART: "THE FOLLOWING COMPLICATIONS ARE POSSIBLE. IF ANY OF THESE CONDITIONS OCCUR, A MEDICAL PROFESSIONAL SHOULD EVALUATE IF THE REMOVAL OF THE PROXICOR IS REQUIRED: PATCH DEHISCENCE OR RUPTURE." IT CAN BE NOTED THAT THE REPORTED SALINE SOAK TIME PRIOR TO USE WAS 10 MINUTES. THE IFU RECOMMENDS SOAK TIME OF 1-2 MINUTES. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 A NEWBORN FEMALE PATIENT UNDERWENT SURGERY FOR A DIAGNOSIS OF AORTIC ARCH HYPOPLASIA AND IVC. AZIYO PROXICOR FOR CARDIAC TISSUE REPAIR (CTR) WAS USED. ONCE THE PATIENT WAS SUTURED, HEMODYNAMIC DETERIORATION OCCURED. ARTERIAL LINE (UMBILICAL ARTERY CANNULATION) CHECKED; MALFUNCTION IS RULED OUT. AN ECOGRAPHY CHECKED THE POSITION OF THE CTR PATCH. SINCE THE HEMODYNAMIC COMPROMISE WAS MAINTAINED, THE PATIENT WAS RECONNECTED TO EXTRACORPOREAL CIRCULATION. ONCE AGAIN EXPOSING THE OPERATIVE FIELD, THE DOCTOR VISUALIZED THAT THE CTR PATCH PRESENTS WHAT HE DESCRIBED AS A "DISSECTION" OF THE SAME. CTR REMOVED AND REPLACED WITH A BAXTER PERI-GUARD PERICARDIUM PATCH. PATIENT SUBSEQUENTLY TAKEN TO NEONATAL ICU WHERE, AFTER A COUPLE OF HOURS, PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129764 PROXICOR FOR CARDIAC TISSUE REPAIR PROXICOR FOR CARDIAC TISSUE REPAIR DXZ AZIYO BIOLOGICS, INC. CMCV-120-404 M19M1538

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Death