BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 10507366 · Received September 9, 2020

    Report

    Report Number
    1213643-2020-08068
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 1, 2019
    Report Date
    September 9, 2020
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    UDI-DI
    00801741129025
    PMA / PMN Number
    K162193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT DEVELOPED ABDOMINAL BULGE 2 YEARS POST-IMPLANT. BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE XENMATRIX AB MAY HAVE CAUSED OR CONTRIBUTED TO THE POSSIBLE HERNIA RECURRENCE. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE AS A POSSIBLE POST-OP COMPLICATION. REVIEW OF MANUFACTURING RECORDS INDICATE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN MARCH, 2017. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED - REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY PRESENTED WITH AN ABDOMINAL BULGE: ON (B)(6) 2017: SUBJECT PATIENT UNDERWENT OPEN SURGERY FOR THE REPAIR OF UMBILICAL, EPIGASTRIC, INFRA UMBILICAL HERNIA MEASURING 20CM X 15CM. SUBJECT PATIENT WAS IMPLANTED WITH XENMATRIX AB SURGICAL GRAFT USING THE RETRO-RECTUS CST/TAR TECHNIQUE. A SWISS CHEESE CONFIGURATION (MULTIPLE DISCREET HERNIAS), WITH CLASS II (CLEAN-CONTAMINATED) WOUND WAS NOTED; WHICH WAS CLEANED OUT PRIOR TO GRAFT PLACEMENT. THE GRAFT WAS TRIMMED TO 25CM X 30CM AND WAS SUTURED IN PLACE USING LONG-TERM ABSORBABLE MULTIFILAMENT SUTURES AT 6 FIXATION POINTS. A MINIMUM OF 5CM OVERLAP WAS ACHIEVED IN ALL DIRECTIONS OF THE INCISION. MIDLINE FASCIA CLOSURE WAS COMPLETED USING LONG-TERM ABSORBABLE SUTURES PLACED 0.8CM APART; SKIN WAS CLOSED USING STAPLES AND 2 DRAINS WERE PLACED IN THE RETRO-RECTUS (RIGHT AND LEFT LOWER QUADRANTS). THE SUBJECT PATIENT WAS ADMINISTERED PROPHYLACTIC ANTIBIOTICS. ON (B)(6) 2017: SUBJECT PATIENT DISCHARGED FROM HOSPITAL. ON (B)(6) 2018: DRAINS WERE REMOVED. ON (B)(6) 2019: SUBJECT PATIENT PRESENTED WITH A GRADE I ABDOMINAL BULGE. THIS ADVERSE EVENT WAS ASSESSED PER THE CLINICIAN TO BE OF MODERATE SEVERITY, AND AS "POSSIBLY RELATED" TO THE STUDY DEVICE AND "POSSIBLY RELATED" TO THE INDEX PROCEDURE. THE BULGE HAD NOT RESOLVED AT THAT TIME. A CT HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976153 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUBP2068 00801741129025

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention