BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 21152554 · Received January 14, 2025

    Report

    Report Number
    1213643-2025-00006
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    September 1, 2020
    Report Date
    January 7, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OWT
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED HERNIA RECURRENCE. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS A LABELED SIDE EFFECT THAT IS CONSIDERED FORESEEABLE AND CLINICALLY ACCEPTABLE IN TERMS OF PATIENT BENEFIT. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR ALLEGED POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE PHASIX ST MESH AND STATES "THERE ARE NO REPORTS OF MESH-RELATED COMPLICATIONS." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-SEP-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 "GIANT HIATAL HERNIA AND P4HB PHASIX TMST MESH HIATOPLASTY OUTCOMES". THIS STUDY EVALUATES THE SAFETY AND EFFICACY OF LONG-LASTING BIOSYNTHETIC ABSORBABLE POLY 4 HYDROXYBUTYRATE PHASIX ST MESH OUTCOMES IN PATIENTS UNDERGOING GIANT HIATUS HERNIA (GHH) REPAIR. THIS WAS A PROSPECTIVE STUDY OF DATABASE OF 44 PATIENTS WHO UNDERWENT LAPAROSCOPIC GHH REPAIR WITH MESH HERNIOPLASTY BETWEEN SEPTEMBER 2020 AND OCTOBER 2023. ONLAY CRURAL REINFORCEMENT WITH THE MESH FOLLOWING THE PRIMARY CLOSURE OF THE HIATAL DEFECT WAS PERFORMED. MESH WAS SECURED USING INTRACORPOREAL ABSORBABLE TACKERS ON THE CRURAL AREA AND ATRAUMATIC FIXATION OF TISSUE GLUE OR SUTURE TO SECURE THE OUTER MESH PERIMETER. IT WAS REPORTED THAT 77% OF PATIENTS WERE FEMALE. THE MAJORITY PERFORMED AS PRIMARY PROCEDURES (88.6%) AND IN ELECTIVE SETTINGS (97.7%), WITH FIVE PATIENTS UNDERGOING THE PROCEDURE FOR RECURRENT HIATUS HERNIA. 4.5% (N=2) EXPERIENCED SIGNIFICANT COMPLICATIONS AT 30 DAYS, WITH ONE PATIENT REQUIRING RETURN TO THEATRE FOR SUSPECTED VISCUS PERFORATION. IN THIS PATIENT, THERE WAS EDEMA AND FLORID INFLAMMATORY CHANGES, SECONDARY TO A SMALL, LOCALIZED PERFORATION, DUE TO COMPLEX TYPE 3/4 HIATUS HERNIA NEEDING EXTENSIVE HIATAL DISSECTION SECONDARY TO ADHESIONS, WITH NO FEATURES OF A FRANK PERFORATION AT RE-LAPAROSCOPY. THE PERFORATION WAS MANAGED CONSERVATIVELY WITH DRAINS AND ANTIBIOTICS. ACUTE KIDNEY INJURY N=2, PNEUMONIA N=1, ATRIAL FIBRILLATION N=1, PNEUMOTHORAX N=1, SUSPECTED VISCUS PERFORATION N=1. 9.1% HAD HIATUS HERNIA RECURRENCE. THE MEDIAN TIME TO RECURRENCE IN THIS COHORT OF PATIENTS WAS SEVEN MONTHS. EARLY RECURRENCE IN OUR SUBGROUP OF PATIENTS BEFORE THE AVERAGE TIME OF PHASIX MESH RESORPTION SUGGESTS THAT OTHER RISK FACTORS, SUCH AS PATIENT AND TECHNICAL-RELATED FACTORS, PLAY A ROLE IN THE RECURRENCE OF HIATUS HERNIA. TO DATE, THERE ARE NO REPORTS OF MESH-RELATED COMPLICATIONS. NOTE: 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
    2011996 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention