BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARISTA AH

    MDR report key: 22036915 · Received May 16, 2025

    Report

    Report Number
    1213643-2025-00390
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    December 15, 2020
    Report Date
    May 2, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    LMG
    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, THE USE OF MPH COULD DECREASE THE DRAINAGE OUTPUT AND THE NUMBER OF DRAINAGE DAYS. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED SEROMA AND NECROSIS COMPLICATIONS. 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. SEROMA AND NECROSIS ARE KNOWN INHERENT RISKS OF SURGERY AND ARE LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATIONS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (15-DEC-2020) 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: ¿CLINICAL EFFECTIVENESS OF MICROPOROUS POLYSACCHARIDE HEMOSPHERES IN MASTECTOMY FOR PATIENTS WITH BREAST CANCER.¿ THE ARTICLE DESCRIBES A SINGLE-CENTER RETROSPECTIVE REVIEW INCLUDED 352 PATIENTS WHO UNDERWENT TOTAL MASTECTOMY FOR BREAST CANCER. PATIENT WERE CATEGORIZED AS TWO GROUPS MICROPOROUS POLYSACCHARIDE HEMOSPHERES (MPH) AND CONTROLLED GROUPS. MPH GROUP HAD 126 PATIENTS WHO UNDERWENT MASTECTOMY WITH OR WITHOUT AXILLARY DISSECTION USING ARISTA AH FROM DECEMBER 2020 AND APRIL 2023 AND CONTROL GROUP HAD 226 PATIENTS WHO UNDERWENT MASTECTOMY WITHOUT USING MPH BETWEEN JANUARY 2015 AND NOVEMBER 2020. SURGICAL PROCEDURES WERE TOTAL MASTECTOMY, MASTECTOMY WITH SENTINEL LYMPH NODE BIOPSY (SLNB) AND MASTECTOMY WITH AXILLARY LYMPH NODE DISSECTION (ALND). THE POSTOPERATIVE COMPLICATIONS OF ARISTA AH MPH GROUP WITH SLNB METHOD INCLUDED SEROMA (17) WITH A NUMBER OF ASPIRATIONS FOR SEROMA AVERAGING 3 TIMES PER PATIENT AND POSTOPERATIVE COMPLICATIONS OF ARISTA AH MPH GROUP WITH ALND METHOD INCLUDED SKIN NECROSIS (1), SEROMA (7) WITH THE NUMBER OF ASPIRATIONS FOR SEROMA AVERAGING 2.3 TIMES PER PATIENT. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. THE ARTICLE CONCLUDES THAT BOTH THE ALND AND SLNB SUBGROUPS, THE DAILY DRAINAGE VOLUME IN THE MPH GROUP REACHED A PLATEAU AND OVERLAPPED WITH THAT OF THE CONTROL GROUP. THERE WAS NO DIFFERENCE BETWEEN THE MPH GROUP AND THE CONTROL GROUP IN POSTOPERATIVE COMPLICATIONS, EXCEPT FOR SKIN NECROSIS. AS A RESULT, WE SHOWED THAT THE USE OF MPH COULD DECREASE THE DRAINAGE OUTPUT AND THE NUMBER OF DRAINAGE DAYS. A DISADVANTAGE OF USING MPH IS THE INCREASED COST OF THE SURGICAL PROCEDURE, BUT THE TOTAL COST EFFECTIVENESS SHOULD BE REVEALED WITH FURTHER STUDY. USE OF MPH IN MASTECTOMY FOR PATIENTS WITH BREAST CANCER WAS ASSOCIATED WITH DECREASED DRAINAGE OUTPUT AND FEWER DRAINAGE DAYS. THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85099 ARISTA AH AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED LMG DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention