BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 12472028 · Received September 14, 2021

    Report

    Report Number
    2210968-2021-08437
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 2, 2014
    Report Date
    August 19, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: BRUCKNER ET AL. JOURNAL OF CARDIOTHORACIC SURGERY 2014, 9:134.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: MICROPOROUS POLYSACCHARIDE HEMOSPHERE ABSORBABLE HEMOSTAT USE IN CARDIOTHORACIC SURGICAL PROCEDURES. AUTHORS: BRIAN A. BRUCKNER, LANCE N. BLAU, LIMAEL RODRIGUEZ, ERIK E. SUAREZ, UY Q. NGO, MICHAEL J. REARDON AND MATTHIAS LOEBE. CITATION:BRUCKNER ET AL. JOURNAL OF CARDIOTHORACIC SURGERY 2014, 9:134. HTTP://WWW.CARDIOTHORACICSURGERY.ORG/CONTENT/9/1/134. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE ALL OF THE CARDIOTHORACIC SURGICAL PROCEDURES CONDUCTED AT A SINGLE CENTER IN WHICH ARISTA® AH WAS USED, AS COMPARED TO AN UNTREATED CONTROL POPULATION. THIS RETROSPECTIVE DATA COLLECTION STUDY WAS DESIGNED TO GATHER INFORMATION FROM ALL PATIENTS THAT UNDERWENT COMPLEX CARDIOTHORACIC SURGICAL INTERVENTIONS (CASES REQUIRING THE USE OF CARDIOPULMONARY BYPASS) FROM JANUARY 2009 TO JANUARY 2013 AT THE HOUSTON METHODIST HOSPITAL (HMH). SAMPLE SIZE FOR THIS RETROSPECTIVE ANALYSIS WAS 240 PATIENTS. THE HISTORICAL CONTROL PATIENTS FROM 2009 TO 2011 RECEIVED AT LEAST ONE HEMOSTATIC AGENT SURGICEL(ETHICON, INC., BRIDGEWATER, NJ). REPORTED COMPLICATIONS INCLUDED VENTILATOR DEPENDENCE (N=21), SHOCK (N=21), RENAL FAILURE (N=23), SEPSIS (N=2), STROKE (N=5), UNPLANNED RE-EXPLORATION <24HRS AND 30DAY MORTALITY 16.1%. IN CONCLUSION USE OF ARISTA AH IN COMPLEX CARDIOTHORACIC SURGERY RESULTED IN A SIGNIFICANT REDUCTION IN HEMOSTASIS TIME, POSTOPERATIVE CHEST TUBE OUTPUT, AND NEED FOR POSTOPERATIVE BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367656 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention