BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 17962704 · Received October 19, 2023

    Report

    Report Number
    9615742-2023-01394
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    May 24, 2023
    Report Date
    October 18, 2023
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: UNKSYMBOTEX - UNKNOWN SYMBOTEX MESH, LOT# UNK LITERATURE EVENTS: DAVID S. LIU, PHD, ZEXI ALLAN, MD, DARREN J. WONG, PHD, SU KAH GOH, PHD, SEAN STEVENS, MSURGED, AHMAD ALY, MS, TIM BRIGHT, MS, DAVID I. WATSON, PHD. PRE-EXISTING HIATAL MESH INCREASES MORBIDITY DURING AND AFTER REVISIONAL ANTIREFLUX SURGERY: A RETROSPECTIVE MULTICENTER STUDY. DR. DAVID S. LIU, PHD, 2023, SURGERY, 10.1016/J.SURG.2023.05.029 JOURNAL HOMEPAGE: WWW.ELSEVIER.COM/LOCATE/SURG ACCEPTED 24 MAY 2023/ AVAILABLE ONLINE 25 JUNE 2023 HTTPS://DOI.ORG/10.1016/J.SURG.2023.05.029 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2010 AND 2020, A RETROSPECTIVE STUDY WHETHER PRE-EXISTING HIATAL MESH IMPACTS POSTOPERATIVE AND INTRAOPERATIVE EVALUATED OUTCOMES IN PATIENTS WHO UNDERWENT REVISIONAL ANTIREFLUX AND HIATUS HERNIA SURGERY BETWEEN 2010 AND 2020. THERE WERE 346 PATIENTS IN THE STUDY WITH 35 MESH APPLIED TO THE HIATUS DURING THEIR PRIMARY OPERATION. MESH TYPES INCLUDED: SYMBOTEX, PARIETEX AND OTHERS. INTRAOPERATIVE ADVERSE EVENTS IN THE PRE-EXISTING MESH GROUP INCLUDED: BLEEDING, LACERATION TO THE PLEURA, LUNG INJURY, LIVER INJURY, GASTRIC INJURY, SPLENIC INJURY AND GASTROESOPHAGEAL RESECTIONS. CONVERSION TO OPEN PROCEDURE AND PROLONGED DURATION OF SURGERY WAS ALSO REPORTED. AS NON-ABSORBABLE MESHES ARE DESIGNED TO INTEGRATE PERMANENTLY WITH SURROUNDING TISSUES, THEY INDUCE INFLAMMATION, TISSUE INGROWTH, AND DENSE ADHESIONS AFTER PROLONGED CONTACT WITH THE PLEURA, LIVER, AND ADJACENT STRUCTURES. THESE PROCESSES OBLITERATE ANATOMICAL PLANES, LEADING TO DIFFICULT AT REVISIONAL SURGERY, PREDISPOSING TO ORGAN INJURY, BLEEDING, AND OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89874 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention