BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEGRAFT

    MDR report key: 7801659 · Received August 21, 2018

    Report

    Report Number
    2247686-2018-00005
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    February 16, 2017
    Report Date
    October 11, 2018
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). ADDITIONAL INFORMATION WAS RECEIVED. THE ARTEGRAFT WAS IMPLANTED AT (B)(6) MEDICAL CENTER BY DR. (B)(6) ON (B)(6) 2016 AND THE PATIENT'S LEG IS VIABLE. CORRECTED: DATE OF EVENT: (4 MONTHS AFTER IMPLANT) ~ (B)(6) 2017. DATE OF IMPLANT IS (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4) ISSUE 1 OF 2. AS THE ARTICLE WAS WRITTEN BASED ON A RETROSPECTIVE REVIEW OF DATA FROM APRIL 2014 TO OCT 2016, A REVIEW OF DATA WAS CONDUCTED. ARTEGRAFT, INC. WAS NOT ABLE TO MATCH THE ISSUES FROM THE JOURNAL ARTICLE TO ANY PREVIOUS COMPLAINTS FROM 2014 TO PRESENT. NO DEVICE EVALUATION WAS ABLE TO BE PERFORMED BECAUSE THE DEVICES WERE NOT RETURNED AND NO LOT NUMBERS WERE PROVIDED. NO CONFIRMED COMPLAINT TREND WAS IDENTIFIED RELATED TO THE ISSUE. ALL PRODUCT QUALITY AND CLINICAL ISSUES WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE ARTICLE LINK IS DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2018.03.343.

    Description of Event or Problem · 1

    UPON LITERATURE REVIEW OF A SCIENTIFIC ARTICLE FROM JOURNAL OF VASCULAR SURGERY VOL 67, NUMBER 6, JUNE 2018 ABSTRACT TITLED "BOVINE CAROTID GRAFT AS A CONDUIT IN ARTERIAL TRAUMA", 2 ISSUES WERE IDENTIFIED; REFER TO MDR 2247686-2018-00006 FOR ISSUE 2 OF 2. THIS CASE WILL CAPTURE THIS ISSUE RELATED TO GRAFT OCCLUDED. THE ARTICLE WAS WRITTEN BASED ON A RETROSPECTIVE REVIEW OF RECORDS FROM APRIL 2014 TO OCT 2016 FOR PATIENTS WITH TRAUMATIC ARTERIAL INJURIES WHO UNDERWENT VASCULAR BYPASS OR INTERPOSITION WITH BOVINE CAROTID ARTERY (ARTEGRAFT). ONE GRAFT (LEFT SFA TO TP TRUNK BYPASS) OCCLUDED AT 4 MONTHS IN A PATIENT WITH A POSTERIOR KNEE DISLOCATION WITH A VIABLE LIMB AFTER FAILED ATTEMPTS AT GRAFT SALVAGE; PRIMARY ASSISTED AND SECONDARY PATENCY AT 4 MONTHS. THERE WERE NO CASES OF GRAFT OR WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642558 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention