BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 21151490 · Received January 14, 2025

    Report

    Report Number
    1213643-2025-00003
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    May 1, 2016
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED HERNIA RECURRENCE. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE AS NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED UPON REQUEST. 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. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, INCLUDED WITH THE PRODUCT AS A POSSIBLE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-MAY-2016) 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: "FIVE-YEAR OUTCOMES FROM A PROSPECTIVE STUDY ON THE SAFETY AND EFFICACY OF PHASIX-ST MESH USE AT THE HIATUS DURING PARAESOPHAGEAL HERNIA REPAIR." THE AIM OF THIS STUDY WAS TO ASSESS THE 5-YEAR HERNIA RECURRENCE RATE AFTER LAPAROSCOPIC PARAESOPHAGEAL HERNIA (PEH) REPAIR USING A COMBINATION OF BIORESORBABLE MESH AND ADVANCED SURGICAL TECHNIQUES IN A PROSPECTIVE GROUP OF PATIENTS. BETWEEN MAY 2016 ¿ JULY 2017 A PROSPECTIVE STUDY OF 50 PATIENTS (32 FEMALES AND 18 MALES) WAS UNDERTAKEN TO ASSESS THE SAFETY AND EFFICACY OF PHASIX-ST BIORESORBABLE MESH FOR CRURAL REINFORCEMENT COMBINED WITH TENSION REDUCING TECHNIQUES AS NECESSARY DURING PRIMARY, ELECTIVE, LAPAROSCOPIC PEH REPAIR. THE AIM OF THIS STUDY WAS TO REPORT THE 5-YEAR OBJECTIVE OUTCOMES IN THIS GROUP. AT A MEDIAN OF 5.25 YEARS OF FOLLOW-UP, IN 27 PATIENTS (20 FEMALES AND 7 MALES), 3 PATIENTS HAD A NEW RECURRENT HERNIA, AND 5 PATIENTS HAD RECURRENT HERNIA (DEFINED AS >2CM) PRIOR TO 5-YEARS. TWO PATIENTS HAD HERNIA RECURRENCE WITH <2CM. HERNIA RECURRENCE WAS NEARLY SIGNIFICANTLY HIGHER IN THE OBESE PATIENTS. TWO PATIENTS UNDERWENT RE-OPERATION FOR HERNIA RECURRENCE. IN PATIENTS THAT HAD A COLLIS GASTROPLASTY, THE HERNIA RECURRENCE RATE WAS UNDER 10%, AND WAS SIGNIFICANTLY LOWER COMPARED TO PATIENTS THAT DID NOT HAVE A COLLIS GASTROPLASTY. THIS FINDING SUGGESTS THAT ESOPHAGEAL SHORTENING IS COMMON IN PATIENTS WITH A PEH AND CONTRIBUTES TO THE HIGH RECURRENCE RATE WITH LAPAROSCOPIC REPAIR. THE LONG-TERM SAFETY AND EFFICACY OF PHASIX-ST MESH IN COMBINATION WITH SURGICAL TECHNIQUE FOR PEH REPAIR IS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897282 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