BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS CARDIOFIX PERICARDIUM

    MDR report key: 10764285 · Received October 30, 2020

    Report

    Report Number
    3004478276-2020-00225
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    November 2, 2011
    Report Date
    July 30, 2021
    Manufacturer
    CORCYM CANADA CORP
    Product Code
    DXZ
    PMA / PMN Number
    K993288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE CARDIOFIX PERICARDIAL PATCH, MODEL # CF 68 , S/N # (B)(6) , AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A MODEL CF 68 CARDIOFIX PERICARDIAL PATCH AT THE TIME OF MANUFACTURE AND RELEASE. SINCE THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, PER THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED. SHOULD FURTHER INFORMATION BECOME AVAILABLE IN THE FUTURE, A FOLLOW UP REPORT WILL BE PROVIDED TO THIS ACTIVITY.

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED THROUGH THE PATHOLOGY REPORT CONFIRMED THAT THE EXPLANTED ASD PATCH PRESENTED ACELLULAR EOSINOPHILIC MATERIAL LINED BY MIXED CELLULAR INFLAMMATION, PREDOMINANTLY HISTIOCYTES, EOSINOPHILS, AND MULTINUCLEATE GIANT CELLS. THE SAMPLED MITRAL ANNULUS CONTAINED FIBROTIC TISSUE WITH ACUTE AND CHRONIC INFLAMMATION AND HEMOSIDEROSIS. THE EXCISED SAMPLE OF ATRIAL SEPTAL DEFECT PATCH ANALYSIS SHOWED AN EXTENSIVELY FIBROTIC TISSUE CONTAINING EMBEDDED SUTURE MATERIAL AND EXHIBITING CALCIFICATION AND OSSIFICATION WITH RECRUITMENT OF HEMATOPOIETIC MARROW ELEMENTS. SINCE THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME AND A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED FOR THIS EVENT. THE MANUFACTURER IS CONDUCTING A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE DEVICE INVOLVED IN THE REPORTED EVENT AND WILL PROVIDE AN UPDATE UPON COMPLETION.

    Description of Event or Problem · 0

    A CARDIOFIX PERICARDIAL PATCH CF 68 WAS PLACED ON (B)(6) 2009 AS PART OF A REPAIR OF RESIDUAL ATRIAL SEPTAL DEFECT. NO PROCEDURAL COMPLICATIONS WERE REPORTED, AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE MANUFACTURER WAS INFORMED THAT THE PATCH WAS REMOVED ON (B)(6) 2011 AND THERE WAS CONCERN FOR ALLERGIC REACTION BASED ON THE PATHOLOGY. PRIOR TO THE RE-INTERVENTION IN (B)(6) 2011, THE PATIENT HAD DEVELOPED SIGNS OF RECURRENT ATRIAL SEPTAL DEFECT WITH A LARGE INTERATRIAL COMMUNICATION. THE ECHOCARDIOGRAM SHOWED A VERY FLOPPY INTERATRIAL PATCH. SIGNIFICANT BIDIRECTIONAL SHUNTING WAS NOTED, AND THE PATIENT WAS REFEREED FOR AN ATRIAL SEPTAL DEFECT CLOSURE. AT THE TIME OF THE RE-INTERVENTION, DURING INSPECTION OF THE INTERATRIAL SEPTUM, IT WAS NOTED THAT THE PREVIOUS ATRIAL SEPTAL PATCH APPEARED TO BE DISINTEGRATING. IT HAD COMPLETELY DETACHED IN THE CENTER AND WAS QUITE FRIABLE. THIS WAS EXCISED AS A SINGLE PATCH. THE LARGE ATRIAL COMMUNICATION WAS THEN CLOSED WITH A PATCH OF GORE-TEX 1 MM THICK MATERIAL. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL.

    Additional Manufacturer Narrative · 1

    UNKNOWN DISPOSITION.

    Description of Event or Problem · 1

    A CARDIOFIX PERICARDIAL PATCH CF68 WAS PLACED IN 2009. THE PATCH WAS REMOVED ON (B)(6) 2011. THE SITE IDENTIFIED THERE WAS CONCERN FOR ALLERGIC REACTION BASED ON THE PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226433 CARBOMEDICS CARDIOFIX PERICARDIUM TISSUE PATCH DXZ CORCYM CANADA CORP CF68

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention