BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXICOR FOR PERICARDIAL CLOSURE

    MDR report key: 10202399 · Received June 26, 2020

    Report

    Report Number
    3005619880-2020-00036
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 26, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    10859389005017
    PMA / PMN Number
    K051405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED FOR DISTRIBUTION ON 05/23/2019 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING FINAL PACKAGING. AS THE REPORTED EVENT OF TAMPONADE IS TYPICALLY ASSOCIATED WITH PLACEMENT/SUTURING OF THE PROXICOR FOR PERICARDIAL CLOSURE DEVICE, A REQUEST FOR SUBASSEMBLY MANUFACTURING LOT REVIEW FROM OUR ECM COMPONENT SUPPLIER WAS NOT MADE AS THERE WERE NO ALLEGATIONS OF DEVICE FAILURE. IT CAN BE NOTED THAT IT APPEARS FROM THE REPORTED INFORMATION THAT THE PROXICOR DEVICE WAS PREPARED (E.G. HYDRATED) PER THE INSTRUCTIONS FOR USE, INCLUDING NO USE OF HEMOSTATIC OR ADHESIVE AGENTS. FOLLOWING DEVICE REMOVAL, PATIENT WAS REPORTED AS RECOVERING. IT CAN BE NOTED THAT PER THE PROXICOR FOR PERICARDIAL CLOSURE INSTRUCTION FOR USE (ART-20707A) PROVIDED WITH THE PACKAGED DEVICE, THAT THE POTENTIAL COMPLICATION OF CARDIAC TAMPONADE IS LISTED FOR THE PROCEDURE AND USE OF THE DEVICE. ALTHOUGH THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, TAMPONADE IS A KNOWN COMPLICATION OF PERICARDIAL CLOSURE. IT IS NOT ANTICIPATED THAT ANY ADDITIONAL INFORMATION WILL BE FORTHCOMING RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 05/29/2020 THAT A PROXICOR FOR PERICARDIAL CLOSURE DEVICE (MODEL CMCV-003-402 LOT# M19E1211) WAS PLACED DURING A PROCEDURE PERFORMED ON (B)(6) 2020 TO CLOSE THE PERICARDIUM ON A (B)(6) MALE PATIENT. ONCE THE PROXICOR WAS IN PLACE, THE PATIENT DEVELOPED SYMPTOMS OF TAMPONADE. DECREASE IN BLOOD PRESSURE (BP), INCREASE IN CARDOVASCULAR PRESSURE (CVP) AND DECREASED LEFT VENTRICULAR (LV) FUNCTION. PROXICOR WAS REMOVED. PHYSICIAN STATED THAT THE PROBABLE CAUSE OF THE EVENT WAS TIGHTNESS DUE TO THE PROXICOR FOR PERICARDIAL CLOSURE DEVICE BEING PLACED. PATIENT IS RECOVERING FOLLOWING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665436 PROXICOR FOR PERICARDIAL CLOSURE PATCH, PLEDGET AND INTRACARDIAC, PETP - DXZ DXZ AZIYO BIOLOGICS, INC. CMCV-003-402 M19E1211 10859389005017

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention