BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 11912522 · Received June 1, 2021

    Report

    Report Number
    3005619880-2021-00017
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    December 3, 2020
    Report Date
    June 1, 2021
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE HOSPITAL PROVIDED THEIR EVALUATION FROM PATHOLOGY LAB WHICH STATED "DIAGNOSIS: RIGHT CAROTID PSEUDOANEURYSM EXCISION REPAIR: ARTERIAL WALL TISSUE WITH MIXED INFLAMMATION AND MURAL DEGENERATIVE CHANGES, CONSISTENT WITH STATED ORIGIN.'" MANUFACTURING REVIEW OF THE VASCURE FOR VASCULAR REPAIR DEVICE HISTORY RECORD FOR THE REFERENCED LOT NUMBER AND RESPECTIVE DEVICE HISTORY RECORD WAS CONDUCTED ON 13MAY2021, SHOWING THAT ALL UNITS WERE QUALITY RELEASED ON 06/09/2020 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS FOR RELEASE. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING THE FINAL PACKAGING. AN ADDITIONAL REQUEST FOR LHR REVIEW WAS MADE TO THE OEM SUPPLIER OF THE ECM AND COMPLETED ON 17MAY2021. THIS REVIEW CONCLUDED THAT ALL DEVICES RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20708A) PROVIDED WITH THE FINISHED VASCURE FOR VASCULAR REPAIR DEVICE, (PSEUDO)ANEURYSM IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE PROCEDURE AND DEVICE. NO ADDITIONAL DETAILS ARE AVAILABLE FOR THE REPORTED EVENT, SHOULD ADDITIONAL DETAILS BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AN AZIYO BIOLOGICS' SALES REPRESENTATIVE VIA EMAIL THAT SURGEON USED A AZIYO VASCURE FOR VASCULAR REPAIR (MODEL #CMCV-014-609, LOT # M20F1174) FOR A DE NOVO CAROTID ENDARTERECTOMY ON (B)(6) 2020. ON ROUTINE POST-OP ULTRASOUND, PSEUDOANEURYSM WAS FOUND IN PATCH. ON (B)(6) 2020, THE PATCH WAS REMOVED AND REPLACED DUE TO A PSEUDOANEURYSM IN THE MIDDLE OF THE PATCH. THE PATIENT IS DOING WELL WITH THE NEW PATCH. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 5/05/2021, ON 5/11/2021 ADDITIONAL INFORMATION RECEIVED FROM HOSPITAL PATHOLOGY STATING DIAGNOSIS AS RIGHT CAROTID PSEUDOANEURYSM, EXCISION REPAIR: ARTERIAL WALL TISSUE WITH MIXED INFLAMMATION AND MURAL DEGENERATIVE CHANGES CONSISTENT WITH STATED ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810448 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ AZIYO BIOLOGICS, INC. CMCV-014-609 M20F1174 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention