BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 8593042 · Received May 8, 2019

    Report

    Report Number
    3005619880-2019-00005
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 8, 2019
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE AZIYO BIOLOGICS DEVICE/LOT HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED ON 1/29/19 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS AND MET CRITERIA FOR MANUFACTURING RELEASE. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE LOT. OEM SUPPLIER REVIEWED THE SUB-LOTS ASSOCIATED WITH THE REPORTED LOT AND IT WAS STATED THAT, "REVIEW CONFIRMS THAT ALL DEVICES MET SPECIFICATIONS." A REVIEW OF THE COMPLAINT LOG SHOWS THAT THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THIS LOT NUMBER. INSTRUCTIONS FOR USE (ART-20708A) UNDER THE SECTION WARNINGS AND PRECAUTIONS IT STATES, "IF DELAMINATION IS OBSERVED, DO NOT USE VASCURE. SUGGESTED INSTRUCTIONS FOR USING VASCURE FOR VASCULAR REPAIR: 5. IF REQUIRED, VASCURE CAN BE CUT TO THE APPROPRIATE SIZE, USING ASEPTIC TECHNIQUE, IN ORDER TO ADEQUATELY COVER THE TISSUE DEFICIENCY/DEFECT OR TREATMENT AREA. IF DELAMINATION IS OBSERVED, DO NOT IMPLANT VASCURE." SAMPLES WERE RETURNED TO AZIYO FOR INVESTIGATION. THE FIRST SAMPLE REVIEWED WAS APPROXIMATELY 4.7CM IN LENGTH, BY APPROXIMATELY 1CM WIDE. THE SAMPLE WAS OBSERVED TO HAVE PEELED BACK APPROXIMATELY 1CM IN LENGTH AND 0.5CM HIGH (OR UP THE WIDTH OF THE SAMPLE). THE SECOND SAMPLE WAS REVIEWED AND WAS OBSERVED TO BE 5CM IN LENGTH, BY APPROXIMATELY 1CM WIDE WITH A PORTION OF SEPARATION/DELAMINATION APPROXIMATELY 1.7CM DOWN THE ENTIRE WIDTH OF THE DEVICE. A SUTURE WAS OBSERVED TO BE ATTACHED TO ONE OF THE ENDS. IT CAN BE NOTED THAT IT APPEARS THAT THE WHOLE PORTION OF THE ORIGINAL PIECE OF VASCURE (1CM BY 10CM) WAS RETURNED IN 2 SAMPLE PORTIONS AS DETAILED ABOVE. NO OTHER REMARKABLE FINDINGS WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCURE FOR VASCULAR REPAIR (MODEL CMCV-014-609, LOT M19A1044) WAS IMPLANTED FOR A CAROTID ENDARTERECTOMY (CEA) PROCEDURE ON (B)(6) 2019 IN A (B)(6) MALE PATIENT. THE DEVICE WAS SOAKED FOR ONE MINUTE IN SALINE. THE DEVICE WAS SUTURED TO CAROTID ARTERY WITH A 7-0 PROLENE SUTURE. NO ADHESIVE AGENTS WERE USED. AFTER IMPLANTING THE PRODUCT ALONG THE CAROTID ARTERY, SURGEON SAYS IT DID NOT LOOK NORMAL AND WAS CONCERNED THAT PRODUCT SEPARATION HAD OCCURRED. THE PRODUCT WAS EXPLANTED ((B)(6) 2019) AFTER THE SURGEON WAS ABLE TO CONFIRM ON ULTRASOUND THAT SEPARATION HAD OCCURRED. A DIFFERENT PRODUCT WAS THEN USED FOR THE PROCEDURE. THE SITE STATES THAT THE EVENT IS NOT RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE AND NO PATIENT COMORBIDITIES. NO CONCERNS WITH PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384028 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ AZIYO BIOLOGICS, INC. CMCV-014-609 M19A1044 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention