BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARISTA AH

    MDR report key: 19004799 · Received March 29, 2024

    Report

    Report Number
    1213643-2024-00114
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    June 1, 2020
    Report Date
    March 12, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    LMG
    UDI-DI
    00801741044090
    PMA / PMN Number
    P050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, IN FOLLOW UP, A CO-AUTHOR OF THE STUDY REPORTED TO BD THAT, "THE CONCLUSION OF THIS ARTICLE IS THAT COMPARED TO TRANEXAMIC ACID, ARISTA POWDER HAS RELATIVELY LESS HEMOSTATIC EFFECT IN SURGERIES SUCH AS TOTAL KNEE ARTHROPLASTY. THEREFORE, I WOULD LIKE TO REITERATE THAT THE USE OF ARISTA POWDER IN TKA SURGERY AND THE RELATIVELY HIGHER BLEEDING DOES NOT MEAN THAT COMPLICATIONS WERE CAUSED BY ARISTA POWDER." THE JOURNAL ARTICLE ITSELF DID NOT INCLUDE ANY ANALYSIS OF HOW OR IF THE ARISTA AH POTENTIALLY CAUSED OR CONTRIBUTED TO ANY PATIENT OUTCOME OR COMPLICATIONS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JUN-2020) IS PROVIDED AS A BEST ESTIMATE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "COMPARISON OF BLOOD LOSS BETWEEN INTRA-ARTICULAR MICROPOROUS POLYSACCHARIDE HEMOSPHERES POWDER AND TRANEXAMIC ACID FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY." AS PER THE JOURNAL ARTICLE, 103 PATIENTS WITH DEGENERATIVE OSTEOARTHRITIS UNDERWENT PRIMARY UNILATERAL OR SIMULTANEOUS BILATERAL TKA (TOTAL KNEE ARTHROPLASTY) BETWEEN JUNE 2020 AND DECEMBER 2021, DURING WHICH MPH (MICROPOROUS POLYSACCHARIDE HEMOSPHERES) POWDER (3 G) WAS APPLIED TO THE IA (INTRAVENOUS OR INTRA-ARTICULAR) SPACE BEFORE CAPSULE CLOSURE MPH GROUP, FOR 51 PATIENTS AND TXA (3 G) WAS INJECTED VIA THE DRAIN AFTER WOUND CLOSURE TXA (TRANEXAMIC ACID) GROUP, FOR 52 PATIENTS. AS REPORTED, THE PRIMARY OUTCOME MEASURE OF THE STUDY WAS DRAIN OUTPUT AND WAS MONITORED AT THE POSTOPERATIVE 0¿24, 24¿48 AND 48¿72 HOURS. THE SECONDARY OUTCOME MEASURES INCLUDED HB (HEMOGLOBIN) LEVELS DURING THE HOSPITALIZATION PERIOD AND THE RATE OF PERIOPERATIVE BLOOD TRANSFUSIONS. CHANGES IN HB LEVELS WERE CALCULATED AND COMPARED BETWEEN THE TWO GROUPS, THE TRIGGER FOR ALLOGENEIC TRANSFUSION OF RED BLOOD CELLS WAS SET AT AN HB LEVEL OF 7 G/DL IN HEALTHY PATIENTS WHO UNDERWENT UNILATERAL TKA AND BETWEEN 8 AND 9 G/DL IN PATIENTS WITH CLINICAL SYMPTOMS AND SIGNS OF ANEMIA. IN PATIENTS UNDERGOING SIMULTANEOUS BILATERAL TKA, TRANSFUSION TRIGGERS INCLUDED THE ABOVE CRITERIA, AND A MORE THAN 3.0 G/DL DECLINE OF THE POSTOPERATIVE HB LEVELS COMPARED TO THOSE PRIOR TO THE OPERATION. AS PER THE OUTCOMES REPORTED ON DRAIN OUTPUT, THE AMOUNT OF DRAIN OUTPUT WAS SIGNIFICANTLY HIGHER IN THE MPH GROUP THAN IN THE TXA GROUP, HOWEVER, THERE WAS NO SIGNIFICANT DIFFERENCE IN THE AMOUNT OF DRAIN OUTPUT THAT WAS MEASURED EVERY 24 HOURS THEREAFTER. AS PER THE OUTCOMES REPORTED ON DIFFERENCE IN HB (HEMOGLOBIN) LEVELS, POSTOPERATIVE HB LEVELS WERE SIGNIFICANTLY LOWER IN THE MPH GROUP COMPARED TO THOSE IN THE TXA GROUP. THE DIFFERENCE IN HB BETWEEN PREOPERATIVE AND POST-OPERATIVE WAS SIGNIFICANTLY GREATER IN THE MPH GROUP THAN IN THE TXA GROUP. AS PER THE OUTCOMES REPORTED ON TRANSFUSION RATE, THE TOTAL TRANSFUSION VOLUME WAS SIGNIFICANTLY HIGHER IN THE MPH GROUP THAN THAT IN THE TXA GROUP, HOWEVER THERE WERE NO SIGNIFICANT DIFFERENCES IN THE TOTAL VOLUME AND TRANSFUSION RATE IN PATIENTS. IT WAS CONCLUDED THAT, IA MPH POWDER CANNOT REPLACE IA TXA BECAUSE OF AN INFERIOR EFFICACY IN REDUCING BLOOD LOSS AND MAINTAINING POSTOPERATIVE HB LEVELS IN THE EARLY POSTOPERATIVE PERIOD AFTER PRIMARY TKA. MOREOVER, IN THE CASE OF SIMULTANEOUS BILATERAL TKA, WE DO NOT RECOMMEND THE USE OF IA MPH POWDER BECAUSE IT WAS NOTABLY LESS EFFECTIVE IN THE FIELD OF TRANSFUSION VOLUME AND RATE. THE CO AUTHOR WOULD LIKE TO REITERATE THAT THE USE OF ARISTA POWDER IN TKA SURGERY AND THE RELATIVELY HIGHER BLEEDING DOES NOT MEAN THAT COMPLICATIONS WERE CAUSED BY ARISTA POWDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2589352 ARISTA AH AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED LMG DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI 00801741044090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention