BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 11051758 · Received December 21, 2020

    Report

    Report Number
    3005619880-2020-00107
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 20, 2021
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K111187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW OF THE VASCURE FOR VASCULAR REPAIR DEVICE HISTORY RECORD SHOWS THAT THE REFERENCED LOT WAS RELEASED TO DISTRIBUTION ON 7/15/2020 HAVING MET ALL AZIYO QUALITY RELEASE REQUIREMENTS. THERE WERE NO NON-CONFORMANCES IDENTIFIED DURING THE MANUFACTURING PROCESS. REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD BY THE COMPONENT LOT MANUFACTURER IDENTIFIED NO MANUFACTUIRNG ISSUES ASSOCIATED WITH THE SPECIFIED LOT THAT WOULD LEAD TO THE REPORTED MATERIAL THICKNESS OR DIFFICULT NEEDLE PENETRATION ISSUE. NEEDLE PENETRATION OF THE ECM MATERIAL CAN BE INFLUENCED BY MANY FACTORS INCLUDING A DAMAGED NEEDLE TIP, ANGLE OF APPROACH TAKEN DURING SUTURING ETC. EVALUATION OF THE LOT SAMPLE FROM SAME BATCH/MANUFACTURING LOT RETURNED FROM THE USER FACILITY FOUND THAT THE DEVICE MET THE ORIGINAL PART SPECIFICATION (DIMENSIONS/VISUAL CHARACTERISTICS) FOR THE SIS-ECM MATERIAL. FURTHER, THE RETURNED LOT SAMPLE WAS FUNCTIONALLY EVALUATED PRIOR TO AND FOLLOWING DEVICE HYDRATION ACCORDING TO THE INSTRUCTIONS FOR USE AND THE SAMPLE HAD NO VISUAL DEFECTS WITHIN THE 1CM X 10CM PIECE OF TISSUE POTENTIALLY CONTRIBUTING TO ALLEGED THICKNESS ISSUES. VISUAL INSPECTION AS WELL AS EVALUATION OF TISSUE FOR POTENTIAL DELAMINATION ISSUES YIELDED NO DISCREPANT RESULTS. AS THE ECM MATERIAL IS A BIOLOGIC MADE FROM DECELLULARIZED PORCINE SMALL INTESTINAL SUBMUCOSAL LAYERS AND LYOPHILIZED, MATERIAL THICKNESS WAS ASSESSED AND FOUND NEGLIGIBLE (~0.002") MATERIAL THICKNESS VARIATION PRIOR TO, AND FOLLOWING HYDRATION UNLIKELY IMPACTING NEEDLE PENETRATION FORCES. WHILE THE EXACT CAUSE OF THE REPORTED EVENT FOR HEMATOMA, AND SUBSEQUENT IDENTIFICATION OF PATCH DEHISCENCE/RUPTURE CANNOT BE CONCLUSIVELY DETERMINED, BOTH HEMATOMA AND PATCH DEHISCENCE ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH CAROTID ENDARTARECTOMY PROCEDURES AND BOTH COMPLICATIONS ARE PROVIDED IN THE VASCURE FOR VASCULAR REPAIR INSTRUCTIONS FOR USE (ART-20708A) PROVIDED WITH EACH DISTRIBUTED DEVICE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME, SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN AZIYO SALES REPRESENTATIVE ON (B)(6) 2020 THAT A 1CM X 10CM VASCURE FOR VASCULAR REPAIR (MODEL #: CMCV-014-609, LOT #: M20G1210) WAS USED IN A CAROTID ENDARTERECTOMY PROCEDURE ON A MALE PATIENT ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A HEMATOMA COVERING HIS RIGHT NECK. THE PATIENT WAS TRANSFERRED TO BAPTIST HEALTH, WHERE THE ORIGINAL IMPLANTING SURGEON ELECTED TO RE-OPEN THE SITE. UPON ACCESSING THE CAROTID ARTERY, THE SURGEON REPORTED THAT THE INTEGRITY OF THE PATCH APPEARED TO BE COMPROMISED, REPORTING THAT THE ECM PATCH APPEARED TO HAVE DISINTEGRATED. IT WAS ALSO NOTED THAT THE IMPLANTING SURGEON RECALLED THE PATCH IN QUESTION BEING DIFFICULT TO PENETRATE WHILE SUTURING DURING THE ORIGINAL PROCEDURE. THE VASCURE PATCH WAS EXPLANTED AND REPLACED WITH BOVINE PERICARDIUM. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509887 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS, INC. CMCV-014-609 M20G1210 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention