BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT

    MDR report key: 9793114 · Received March 5, 2020

    Report

    Report Number
    2247686-2020-00001
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    October 28, 2019
    Report Date
    March 5, 2020
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTEGRAFT, INC. IDENTIFIED THE ADVERSE EVENT (REPORT NUMBER (B)(4)) ON 02/06/2020 DURING A ROUTINE REVIEW OF THE (B)(4) DATABASE. THE ADVERSE EVENT WAS SUBMITTED DIRECTLY BY THE HOSPITAL TO THE FDA AS A USER REPORT AND A COPY WAS NOT RECEIVED BY ARTEGRAFT, INC. THE ARTEGRAFT, INC. AWARE DATE IS (B)(6) 2020. IN FOLLOW-UP COMMUNICATIONS, THE IMPLANTING PHYSICIAN REPORTED TO THE LOCAL SALES REPRESENTATIVE THAT FOLLOWING THE GRAFT REPAIR, THE PATIENT IS "DOING GREAT". ADDITIONAL INFORMATION AND DETAILS INCLUDING PATIENT INFORMATION WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED. IT WAS ALSO REQUESTED IF THE GRAFT WAS PRESSURE TESTED PER THE IFU PRIOR TO IMPLANT. AS THIS IS A KNOWN POSSIBLE ISSUE, ARTEGRAFT, INC. INSTRUCTIONS FOR USE INCLUDE INSTRUCTIONS FOR PRESSURE TESTING EACH GRAFT PRIOR TO IMPLANT. THE PREPARATION FOR IMPLANT SECTION STATES, "ARTEGRAFT IS MANOMETRY PRESSURE TESTED AND QUALITY INSPECTED. BEFORE IMPLANTING, OCCLUDE ONE END OF GRAFT AND PRESSURE TEST WITH SYRINGE FILLED WITH SALINE SOLUTION." A REVIEW OF THE DEVICE HISTORY RECORD FOR BATCH 19D109 WAS PERFORMED; NO ABNORMALITIES WERE IDENTIFIED. ALL GRAFTS RELEASED FROM BATCH 19D109 PASSED THE REQUIREMENTS FOR RELEASE, INCLUDING PRESSURE TESTING, STERILITY TESTING, AND FINAL VISUAL INSPECTION PRIOR TO RELEASE TO FINISHED GOODS.TO DATE, NO ADDITIONAL COMPLAINTS WERE REPORTED FROM THIS PRODUCT BATCH. A REVIEW OF THE IMPLANT RECORD VERIFIES THAT GRAFT LOT 19D109-047 WAS IMPLANTED BY DR. (B)(6) ON (B)(6) 2019. AS THE GRAFT LOT 19D109-047 REMAINS IMPLANTED, IT IS UNAVAILABLE FOR EVALUATION AT ARTEGRAFT, INC. ARTEGRAFT, INC. MANUFACTURING PERSONNEL WERE MADE AWARE OF THIS EVENT. THIS ISSUE WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING.

    Description of Event or Problem · 1

    REVIEW OF THE FDA (B)(4) DATABASE IDENTIFIED A REPORT RELATED TO ARTEGRAFT, INC.; REPORT NUMBER (B)(4). "PT HAD A FEMORAL BYPASS ON (B)(6) 2019 DURING WHICH A BOVINE CAROTID ARTERY GRAFT "ARTEGRAFT" WAS UTILIZED. PT PRESENTED IN CLINIC ON (B)(6) 2019 WITH LOWER ABDOMINAL HEMATOMA. PT TAKEN EMERGENTLY TO OPERATING ROOM FOR EXPLORATION OF GRAFT SITE AND POSSIBLE REPAIR. IT WAS DISCOVERED THAT THERE WAS NO BLEEDING FROM THE ANASTOMOSIS SITE. HOWEVER, AT 6 CM PROXIMAL TO THE DISTAL ANASTOMOSIS THERE WAS PULSATILE BLEEDING FROM A TEAR DROP SHAPED HOLE THAT WAS CONTROLLED WITH THE PLACEMENT OF A SUTURE. THE SURGEON IDENTIFIED THE HOLE WAS POSSIBLY RELATED TO WHERE ONE OF THE SIDE BRANCHES WOULD HAVE BEEN TIED OFF BY THE MANUFACTURER ON THE BOVINE ARTERY. RISKS THAT HAD BEEN REVIEWED WITH THE PT INCLUDED BLEEDING AND POSSIBLE MANUFACTURER DEFECTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259052 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC. AG840 19D109-047

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention