BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 10736414 · Received October 26, 2020

    Report

    Report Number
    3005619880-2020-00075
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 26, 2020
    Manufacturer
    AZIYO BIOLOGICS INC
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE VASCURE FOR VASCULAR REPAIR DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL FINAL PACKAGED AND LABELED UNITS WERE QUALITY RELEASED TO DISTRIBUTION ON 04/29/2020 HAVING MET ALL INTERNAL AZIYO QC ACCEPTANCE REQUIREMENTS. DEVICE MANUFACTURE AND STERILIZATION ACTIVITIES ARE PERFORMED BY A CONTRACT MANUFACTURER, REQUEST FOR REVIEW OF ASSOCIATED BATCH AND STERILIZATION RECORDS INDICATE NO NONCONFORMANCES ASSOCIATED WITH THE SUBASSEMBLIES UTILIZED IN THIS MANUFACTURING LOT. IT IS ALSO NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20708A) PROVIDED WITH THE FINISHED VASCURE FOR VASCULAR REPAIR DEVICE, HEMATOMA, PATCH DEHISCENCE/ RUPTURE (DETERIORATION), AND INFECTION ARE LISTED AS A POTENTIAL COMPLICATIONS ASSOCIATED WITH AN ENDARTARECTOMY PROCEDURE AND DEVICE USAGE. IT IS FURTHER NOTED THAT KLEBSIELLA BACTERIA (PNEUMONIA, OR OXYTOCA) ARE MOSTLY SPREAD THROUGH PERSON-TO-PERSON CONTACT. LESS COMMONLY, THEY ARE SPREAD BY CONTAMINATION IN THE ENVIRONMENT. AS WITH OTHER HEALTHCARE-ASSOCIATED INFECTIONS, THE BACTERIA CAN BE SPREAD IN A HEALTH CARE SETTING VIA THE CONTAMINATED HANDS OF HEALTH CARE WORKERS. ALTHOUGH THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE CONCLUSIVELY DETERMINED THE REPORTED HEMATOMA OR RESULTING DEHISCENCE/ RUPTURE (DETERIORATION) ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE USE OF A VASCURE FOR VASCULAR REPAIR AND A SURGICAL IMPLANT PROCEDURE. 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 ON 09/24/2020 BY A AZIYO SALES REPRESENTATIVE THAT THEY SPOKE WITH PHYSICIAN THIS MORNING REGARDING AN ADVERSE EVENT RELATED TO AN IMPLANT OF A AZIYO VASCURE (MODEL #: CMCV-014-609; LOT #: M20D1145) PERFORMED ON (B)(6) 2020 FOR A CAROTID ENDARTERECTOMY ON A RELATIVELY YOUNG AND OTHERWISE HEALTHY PATIENT. THE PATIENT RETURNED THIS WEEK WITH A HEMATOMA AND WAS REOPERATED ON THIS MORNING. THE PATCH WAS FOUND TO HAVE DISINTEGRATED AT THE CORNER FOR NO APPARENT REASON. A SAMPLE WAS SENT FOR TO THE HOSPITAL PATHOLOGY LAB FOR HISTOLOGY. UPON EXPOSURE DURING RE-OP, THE PHYSICIAN OBSERVED THAT THE VASCURE PATCH HAD DEHISCED IN THE CENTER, WITH ORIGINAL SUTURES LEFT INTACT ANCHORING THE PATCH TO THE ARTERY. FURTHER INFORMATION RECEIVED FROM PHYSICIAN INDICATING THAT THE HOSPITAL LAB SAMPLE WAS FOUND TO HAVE BEEN INFECTED WITH KLEBSIELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198828 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET & INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS INC CMCV-014-609 M20D1145 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention