BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH® BIOMATERIAL

    MDR report key: 9649122 · Received January 30, 2020

    Report

    Report Number
    3003910212-2020-00009
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    March 22, 2016
    Report Date
    April 9, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K992189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE REPORTED 86.0% MALE AND THE MEDIAN AGE WAS 62 YEARS.

    Additional Manufacturer Narrative · 1

    ADDITIONALLY, EVENT INFORMATION SUCH AS ITEM/LOT NUMBER, IMPLANT DATE, DATE OF EXPLANT, PATIENT MEDICAL HISTORY WERE REQUESTED, HOWEVER NO INFORMATION HAS BEEN RECEIVED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR GORE® DUALMESH® BIOMATERIAL COMPLICATIONS MAY INCLUDE BUT ARE NOT LIMITED TO, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION,PERFORATION, WOUND DEHISCENCE, WOUND COMPLICATIONS, PAIN, BOWEL OBSTRUCTION, ILEUS, REVISION/RE-INTERVENTION, FEVER AND RECURRENCE.

    Description of Event or Problem · 1

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: (THE MANAGEMENT OF THE DIAPHRAGM DURING RADICAL SURGERY FOR MALIGNANT PLEURAL MESOTHELIOMA). PER THE ARTICLE: THE AIM OF RADICAL SURGERY IN MALIGNANT PLEURAL MESOTHELIOMA (MPM) IS TO OBTAIN MACROSCOPIC COMPLETE RESECTION, WHICH REQUIRES RESECTION OF ALL VISIBLE TUMOURS WITHIN THE AFFECTED HEMITHORAX. A STUDY OF 314 PATIENTS, 86.0% MALE, MEDIAN AGE 62 YEARS (RANGE 14¿81 YEARS) UNDERGOING RADICAL SURGERY FOR MPM, BY EITHER EPD OR EXTRAPLEURAL PNEUMONECTOMY. PATIENTS WERE IDENTIFIED FROM OUR PROSPECTIVELY UPDATED INSTITUTIONAL DATABASE OF ALL PATIENTS UNDERGOING RADICAL RESECTION BY EITHER EPP OR EXTENDED PLEURECTOMY¿DECORTICATION (EPD) FOR MPM BETWEEN 1999 AND 2014. OPERATIVE TECHNIQUES: BOTH EPP AND EPD WERE PERFORMED USING STANDARDIZED TECHNIQUES AS DEFINED BY THE INTERNATIONAL ASSOCIATION FOR THE STUDY OF LUNG CANCER INTERNATIONAL STAGING COMMITTEE AND THE INTERNATIONAL MESOTHELIOMA INTEREST GROUP. EPP WAS PERFORMED VIA A MEDIAN STERNOTOMY IN THE MAJORITY OF CASES, WITH EN BLOC RESECTION OF THE LUNG, PERICARDIUM AND HEMIDIAPHRAGM. EPD WAS PERFORMED VIA A POSTEROLATERAL THORACOTOMY THROUGH THE SIXTH INTERCOSTAL SPACE, WITH A SECOND-LEVEL THORACOTOMY PERFORMED IF REQUIRED, IN ALL BUT 2 CASES WHERE MEDIAN STERNOTOMY WAS PERFORMED TO GIVE ACCESS TO INTRAPERICARDIAL STRUCTURES. EPD IS PERFORMED BY PARIETAL PLEURECTOMY AND COMPLETE VISCERAL DECORTICATION, INCLUDING THE FISSURES, AND RESECTION OF THE PERICARDIUM AND HEMIDIAPHRAGM. IN BOTH PROCEDURES, THE PERICARDIUM WAS REPLACED USING AN ABSORBABLE MESH PATCH. IN THE MAJORITY OF CASES, A GORE-TEX PATCH WAS USED TO REPLACE THE HEMIDIAPHRAGM. IT WAS CONFIRMED BY GORE THAT THE REPORTED "GORE-TEX PATCH" WAS GORE® DUALMESH® BIOMATERIAL. THE ARTICLE REPORTS "SEVENTEEN PATIENTS (85%) UNDERWENT REOPERATION FOR PATCH REMOVAL ± REPLACEMENT IMMEDIATELY FOLLOWING THE DIAGNOSIS OF DEHISCENCE. IN ONLY 4 CASES WAS THERE EVIDENCE OF PATCH INFECTION AT REOPERATION (23.6%)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112959 GORE DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O