BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARISTA AH

    MDR report key: 22036927 · Received May 16, 2025

    Report

    Report Number
    1213643-2025-00392
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    December 15, 2019
    Report Date
    May 5, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    LMG
    UDI-DI
    00801741044120
    PMA / PMN Number
    P050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. BASED ON THE CONTENTS OF THE ARTICLE, INCORPORATION OF MPH HEMOSTATIC AGENTS INTO STANDARD PRACTICE MAY BENEFIT TO MITIGATE PH RISK DURING CIED IMPLANTATIONS IN PATIENTS ON ANTITHROMBOTIC THERAPY. INCORPORATING MPH HEMOSTATIC AGENTS DURING CIED IMPLANTATIONS IN SUCH PATIENTS MAY BE CONSIDERED AS A VALUABLE ADDITION. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED HEMATOMA COMPLICATION. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR ALLEGED POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE ARISTA AH. HEMATOMA IS KNOWN INHERENT RISKS OF SURGERY AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (15-DEC-2019) IS CONSIDERED TO BE 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: "MICROPOROUS POLYSACCHARIDE HEMOSPHERES FOR REDUCING POCKET HEMATOMAS AFTER CARDIAC DEVICE IMPLANTATION IN PATIENTS ON ANTITHROMBOTIC THERAPY." THE ARTICLE DESCRIBES A SINGLE-CENTER RETROSPECTIVE STUDY AIMED TO INVESTIGATE THE POTENTIAL BENEFITS OF USING (MICROPOROUS POLYSACCHARIDE HEMOSPHERES) MPH HEMOSTATIC AGENTS DURING (CARDIAC IMPLANTABLE ELECTRONIC DEVICES) CIED IMPLANTATIONS AS A PREVENTIVE MEASURE AGAINST POST-PROCEDURAL (POCKET HEMATOMA) PHS. THE STUDY CONDUCTED WITH 255 CONSECUTIVE JAPANESE PATIENTS WHO UNDERWENT CIED IMPLANTATION BETWEEN NOVEMBER 2017 AND APRIL 2022. PATIENTS WHO UNDERWENT CIED IMPLANTATION BETWEEN NOVEMBER 2017 AND NOVEMBER 2019 HAD CIED PROCEDURES WITHOUT MPH HEMOSTATIC AGENTS, WHILE PATIENTS FROM DECEMBER 2019 TO APRIL 2022 HAD CIED PROCEDURES WITH MPH HEMOSTATIC AGENTS (1G DOSE OF HEMOSTATIC AGENT). THE POSTOPERATIVE COMPLICATIONS OF ARISTA AH INCLUDE POCKET HEMATOMA WAS OBSERVED WITHIN 28 DAYS POST-OPERATION IN 9 PATIENTS WHO RECEIVED MPH HEMOSTATIC AGENTS AND IN 13 PATIENTS WITHOUT MPH HEMOSTATIC. THE ARTICLE CONCLUDES THAT THE FINDINGS OF THIS STUDY SUGGEST THAT THE INCORPORATION OF MPH HEMOSTATIC AGENTS INTO STANDARD PRACTICE MAY BENEFIT TO MITIGATE PH RISK DURING CIED IMPLANTATIONS IN PATIENTS ON ANTITHROMBOTIC THERAPY. INCORPORATING MPH HEMOSTATIC AGENTS DURING CIED IMPLANTATIONS IN SUCH PATIENTS MAY BE CONSIDERED AS A VALUABLE ADDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67303 ARISTA AH AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED LMG DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI 00801741044120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention