BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXICOR FOR CARDIAC TISSUE REPAIR

    MDR report key: 10608322 · Received September 30, 2020

    Report

    Report Number
    3005619880-2020-00068
    Event Type
    Death
    Date Received
    September 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005041
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IDENTIFICATION INFORMATION (E.G. MODEL NUMBER, LOT NUMBER), OR DATES OF TREATMENT, DEATH ETC. DESPITE MULTIPLE ATTEMPTS AND USAGE OF MULTIPLE POINTS OF CONTACT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ALTHOUGH ROOT CAUSE CANNOT BE CONCLUSIVELY ESTABLISHED, THE NOTED MIGRATION OF THE ESOPHAGEAL STENT FROM THE LEFT ATRIUM LEADING TO THE REPORTED BACTERIAL INFECTION. THE INSTRUCTIONS FOR USE FOR THE PROXICOR FOR CARDIAC TISSUE REPAIR LISTS INFECTION AS A POTENTIAL COMPLICATION. ANY ADDITIONAL INFORMATION RECEIVED WILL BE PROVIDED IN A SUBSEQUENT FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON 6/18/2020, AZIYO BIOLOGICS CONTRACT MANUFACTURER NOTIFIED AZIYO OF A RECENTLY ACCEPTED FOR PRINT ARTICLE IN PACING AND CLINICAL ELECTROPHYSIOLOGY (PACE) [REFERENCE: PACING CLIN ELECTROPHYSIOL. 2020 JUN 16. DOI: 10.1111/PACE.13988. ONLINE AHEAD OF PRINT]. THE ARTICLE TITLED "SURGICAL AND ENDOSCOPIC MANAGEMENT OF A PERICARDIOESOPHAGEAL FISTULA AFTER RADIOFREQUENCY PULMONARY VEIN ISOLATION MANAGEMENT OF A PERICARDIOESOPHAGEAL FISTULA" WAS EPUBLISHED ON JUNE 16, 2020. THIS ARTICLE WAS DISCOVERED DURING THE CONTRACT MANUFACTURER'S LITERATURE REVIEW CYCLE AND REVIEWED IN SUPPORT OF AZIYO BIOLOGICS POST MARKET SURVEILLANCE PROCESS. THE CASE STUDY REPORTS THE EVENTS RELATIVE TO A (B)(6) YEAR OLD MALE PATIENT HAVING PREVIOUSLY UNDERGONE AN RF PULMONARY VEIN ISOLATION PROCEDURE 3 WEEKS PRIOR, PRESENTED WITH CHEST PAIN. CTA AND ECHOCARDIOGRAM SHOWED PNEUMOPERICARDIUM AND BARIUM ESOPHAGRAM SHOWED EXTRAVASATION FROM ESOPHOGUS INTO THE PERICARDIUM WITHOUT CONNECTION TO THE LEFT ATRIUM. PERICARDIAL DEFECT WAS IDENTIFIED AND A CORMATRIX (NOW AZIYO BIOLOGICS INC.) PROXICOR ECM PATCH WAS PLACED (MODEL #: UNKNOWN, LOT #: UNKNOWN - LIKELY PROXICOR FOR CARDIAC TISSUE REPAIR). THE FISTULA RESULTING FROM EXTRAVASATION FROM ESOPHAGUS WAS REPAIRED VIA ENDOSCOPIC STENT PLACEMENT. PATIENT DISCHARGED FOLLOWING CONFIRMATION VIA BARIUM TEST OF NO LEAKAGE. ONE WEEK LATER PATIENT RETURNED FOLLOWING UNWITNESSED FALL HAVING ENTEROCOCCAL AND CANDIDA BACTEREMIA AND AN ACUTE RIGHT PARIETAL/OCCIPITAL LOBE INFARCT. BARIUM ESOPHAGRAM SHOWED CONTRAST EXTRAVASATION INTO THE PERICARDIUM. INITIAL BLOOD CULTURES WERE POSITIVE FOR VANCOMYCIN-RESISTANT ENTEROCOCCUS FAECIUM AND CANDIDA GLABRATA FOR WHICH APPROPRIATE DOSES OF LINEZOLID AND VORICONAZOLE WERE INITIATED, RESPECTIVELY. WITHIN FIVE DAYS OF READMISSION, THE PATIENT DEVELOPED A BRADYCARDIC ARREST AND SUCCUMBED TO HIS ILLNESS. ATTEMPTS TO CONTACT CORRESPONDING AUTHOR GENERATED ONLY THE INFORMATION THAT THIS PATIENT WAS TREATED ABOUT 4 YEARS AGO AND NO LONGER WORKS AT THIS HOSPITAL. ADDITIONAL ATTEMPTS TO REACH OTHER AUTHORS HAVE NOT PROVIDED ANY ADDITIONAL DATES OF TREATMENT, DEATH, AZIYO PRODUCT / LOT NUMBER INVOLVED ETC. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070520 PROXICOR FOR CARDIAC TISSUE REPAIR PATCH. PLEDGET AND INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS, INC. CMCV-064-401 00859389005041

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R