BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM PERICARDIAL PATCH WITH ENCAP AC TECHNOLOGY

    MDR report key: 5917332 · Received August 31, 2016

    Report

    Report Number
    9680759-2016-00001
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    May 12, 2016
    Report Date
    August 2, 2016
    Manufacturer
    GLYCAR S.A. (PTY.) LTD.
    Product Code
    DXZ
    PMA / PMN Number
    K963967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. THESE INCLUDED INSPECTIONS DURING THE MANUFACTURING PROCESS TO ENSURE THE STERILIZATION OF THE PATCH WAS PERFORMED ACCORDING TO THE VALIDATED PROCESS AND THE BATCH PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. SJM HAS NO DATA TO SUPPORT THE USE OF GLUTARALDEHYDE-FIXED TISSUE OUTSIDE CARDIAC AND VASCULAR REPAIRS AND THE USE OF THIS PRODUCT IN THE OCULAR SPACE IS CONSIDERED OFF-LABEL.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. THESE INCLUDED INSPECTIONS DURING THE MANUFACTURING PROCESS TO ENSURE THE STERILIZATION OF THE PATCH WAS PERFORMED ACCORDING TO THE VALIDATED PROCESS AND THE BATCH PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 AN SJM PERICARDIAL PATCH WITH ENCAP TECHNOLOGY WAS IMPLANTED ON THE PATIENT'S SCLERA. ON (B)(6) 2016, THE PATIENT DEVELOPED AN INFLAMMATORY REACTION OF THE CONJUNCTIVA AND THE SUSPECTED CAUSE WAS REPORTED TO BE DUE TO A REJECTION OF THE PATCH MATERIAL BY THE PATIENT'S TISSUE. AFTER THE PERICARDIAL PATCH WAS REMOVED, THE INFLAMMATION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570160 SJM PERICARDIAL PATCH WITH ENCAP AC TECHNOLOGY PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ GLYCAR S.A. (PTY.) LTD. C0510 4773731

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention