BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX PLUS

    MDR report key: 8405977 · Received March 8, 2019

    Report

    Report Number
    3005920706-2019-00003
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 12, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190001240
    PMA / PMN Number
    K162559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED FASCIAL DEHISCENCE WITH BOWEL OBSTRUCTION REQUIRING EMERGENT SURGERY AND HOSPITALIZATION. UPON EXPLORATION FOR MANAGEMENT OF THE EVENT, IT WAS THE OPERATING SURGEON'S OPINION THAT THE FASCIAL DEHISCENCE WAS NOT THE RESULT OF ACELL DEVICE FAILURE; THAT THE DEVICE PERFORMED AS EXPECTED, THAT THE FASCIAL DEHISCENCE WAS, IN FACT, THE PRIMARY EVENT AND THAT THE EVENT RESULTED FROM PATIENT FACTORS AND INHERENT PATIENT COMORBIDITIES. THE ACELL DEVICE WAS EXPLANTED AND DISCARDED BY THE HOSPITAL, IT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES. ACELL CONDUCTED SUTURE RETENTION TESTING ON THE SAME RETAINED LOT WHICH MET SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ACELL, INC. WAS NOTIFIED BY A SURGEON THAT A PATIENT HAD A FASCIAL DEHISCENCE WITH BOWEL OBSTRUCTION REQUIRING EMERGENT SURGERY AND HOSPITALIZATION ON (B)(6) 2019. THE SURGEON OBSERVED THAT THE PRIMARY SUTURES USED TO CLOSE THE DEFECT HAD RUPTURED ALONG WITH THE IMPLANTED ACELL DEVICE WHICH HAD BEEN PLACED AS AN UNDERLAY. THE SURGEON INFORMED ACELL THAT THE PATIENT HAD BEEN NON-COMPLAINT WITH POST-OPERATIVE ACTIVITY INSTRUCTIONS. THE SURGEON EXPLANTED AND DISCARDED THE ACELL DEVICE. THE SUBSEQUENT REPAIR WAS COMPLETED WITH A NON-ACELL DEVICE, A SYNTHETIC MESH. THERE WAS NO INFECTION PRESENT AFTER ACELL IMPLANTATION OR AT ACELL EXPLANTATION. THE PATIENT DEVELOPED AN INFECTION AFTER IMPLANTATION OF THE SYNTHETIC MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197840 GENTRIX SURGICAL MATRIX PLUS GENTRIX SURGICAL MATRIX PLUS FTM ACELL, INC. MSPL1015 014449 00386190001240

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R