BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 21151459 · Received January 14, 2025

    Report

    Report Number
    1213643-2025-00002
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    January 1, 2023
    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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED MINOR COMPLICATIONS AND SOME UNDERWENT SURGICAL REVISION. 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 PHASIX ST MESH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2023) 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, "LIMITATIONS OF TRANSVERSUS ABDOMINIS RELEASE (TAR)¿ADDITIONAL BRIDGING OF THE POSTERIOR LAYER AND/OR ANTERIOR FASCIA IS THE PREFERRED SOLUTION IN OUR CLINICAL ROUTINE IF PRIMARY CLOSURE IS NOT POSSIBLE." AS REPORTED PER JOURNAL ARTICLE, IN THE PERIOD OF 01-JAN-2023 TO 31-DEC-2023, 88 MEDIAL AND 15 LATERAL INCISIONAL HERNIAS AND 9 PARASTOMAL HERNIAS WERE OPERATED IN HOSPITAL. OF THESE 112 PATIENTS, ONLY THOSE, (N = 50); (MEDIAL: N = 27, LATERAL: N = 14, PARASTOMAL: N = 9) WHO UNDERWENT OPEN OR MINIMALLY INVASIVE TRANSVERSUS ABDOMINIS RELEASE WITH MESH PLACEMENT WERE ANALYZED IN THIS STUDY. POSTERIOR BRIDGING TECHNIQUE WAS PERFORMED WITH IMPLANT OF A LONG-TERM ABSORBABLE MESH MADE OF POLY-4-HYDROXYBUTYRATE WITH SEPRA COATING - PHASIX ST MESH WHICH HAS PROVEN ITS EFFECTIVENESS IN PRACTICE. POSTOPERATIVE COMPLICATIONS WERE GRADED ACCORDING TO THE DINDO-CLAVIEN CLASSIFICATION SYSTEM. MINOR COMPLICATIONS OCCURRED IN 18% (N = 9) OF CASES, SURGICAL REVISION WAS NEEDED IN THREE CASES (6%), MORTALITY (CD5) WAS 2% (N = 1) DUE TO ONE PATIENT DYING OF FULMINANT PULMONARY EMBOLISM DURING MOBILIZATION ON POSTOPERATIVE DAY 1 FOLLOWING A ROBOTIC PAULI PROCEDURE. IT WAS CONCLUDED THAT TAR IS AN IMPORTANT SURGICAL TOOL IN THE REPAIR OF VENTRAL AND PARASTOMAL HERNIAS. IT OFFERS UNIQUE OPPORTUNITIES THROUGH THE TENSION-FREE PLACEMENT OF MESHES WITH ADEQUATE OVERLAP. POSTERIOR BRIDGING IS A USEFUL ADJUNCT THAT CAN BE USED HERE DEPENDING ON THE INTRAOPERATIVE FINDINGS. THEREFORE, THIS CONCEPT OFFERS VERY HIGH FLEXIBILITY IN THE ROUTINE TREATMENT OF THESE PATIENTS. NOTE: THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT PATIENTS EXPERIENCED MINOR COMPLICATIONS AND THREE UNDERWENT SURGICAL REVISION. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION, OR ALLEGED POST-OP COMPLICATION WERE CAUSED OR CONTRIBUTED TO THE USE OF THE PHASIX ST MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011512 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