BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEGRAFT

    MDR report key: 7801683 · Received August 21, 2018

    Report

    Report Number
    2247686-2018-00006
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    April 23, 2014
    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) 2014 THE PATIENT HAD A "NONVIABLE MANGLED EXTREMITY DESPITE BYPASS AND UNDERWENT AMPUTATION". CORRECTED: DATE OF EVENT: (B)(6) 2014. DATE OF IMPLANT IS (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4) ISSUE 2 OF 2. THE ARTICLE WAS WRITTEN BASED ON A RETROSPECTIVE REVIEW OF DATA FROM APRIL 2014 TO OCT 2016. 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 2247686-2018-00005 FOR ISSUE 1 OF 2. THIS CASE WILL CAPTURE THIS ISSUE RELATED TO "THERE WAS ONE EARLY FAILURE, WITH RESULTANT ABOVE KNEE AMPUTATION, ON POSTOPERATIVE DAY 1." 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). THE PATIENT WAS IN A MOTORCYCLE COLLISION AND SUFFERED A MANGLED LEFT LOWER EXTREMITY. INTERVENTION INCLUDED LEFT COMMON FEMORAL ARTERY (CFA) TO ABOVE KNEE POPLITEAL BYPASS. THE PATIENT RETURNED TO THE OR ON POSTOPERATIVE DAY 1 WITH NONSALVAGEABLE EXTREMITY WITH RESULTANT ABOVE KNEE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642985 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability