BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGEL PLATINUM PLUERAL AIR LEAK SEALANT

    MDR report key: 23265962 · Received October 10, 2025

    Report

    Report Number
    1213643-2025-00973
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    January 1, 2018
    Report Date
    September 25, 2025
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    PMA / PMN Number
    P010047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS AND NEEDED HOSPITALIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT CURRENTLY, THE INFORMATION IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT THAT ANY SPECIFIC DEVICE MALFUNCTION OR ALLEGED POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE PROGEL PLATINUM. REVIEW OF THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, IDENTIFIES PNEUMONIA, EMBOLISM AND PLEURAL EFFUSION AS POSSIBLE ADVERSE REACTIONS AND ARE CONSIDERED FORESEEABLE AND CLINICALLY ACCEPTABLE IN TERMS OF PATIENT BENEFIT. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2018) 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 ARTICLE: "FEASIBILITY OF VIDEO-ASSISTED THORACOSCOPIC SURGERY AS A REDO CHEST APPROACH FOR LUNG RESECTION IN PATIENTS WITH A HISTORY OF SURGICAL PROCEDURES ON THE SAME SIDE" THE AIM OF THIS STUDY WAS TO REPORT THE RESULTS OF VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) AS SURGICAL APPROACH FOR REINTERVENTION AFTER A PREVIOUS IPSILATERAL INTRATHORACIC SURGERY. THIS RETROSPECTIVE MONOCENTRIC OBSERVATIONAL STUDY REQUIRED REVIEW OF MEDICAL FILES OF PATIENTS UNDERGOING MINIMALLY INVASIVE IPSILATERAL REDO SURGERY BETWEEN 2018 AND 2023, INCLUDING 38 PATIENTS WHO UNDERWENT REDO VATS ABOUT 22 MALES AND 16 FEMALES. VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LUNG RESECTION OPERATIONS (21 LOBECTOMIES, 3 SEGMENTECTOMIES 14 WEDGE RESECTIONS) WERE SAFELY PERFORMED IN PATIENTS WHO UNDERWENT PREVIOUS IPSILATERAL CHEST SURGERY (REDO). VARIOUS AEROSTATIC PRODUCTS (TACHOSIL, TAKEDA, JAPAN; PROGEL, BECTON DICKINSON, USA; NEOVEIL, GUNZE, USA) WERE UTILIZED BASED ON THE SURGEON¿S PREFERENCE. A SUBGROUP ANALYSIS WAS PROPOSED BASED ON THE MOST RELEVANT FACTORS TO CONSIDER WHEN PLANNING A REDO THORACIC PROCEDURE: CATEGORY OF PROCEDURE (LUNG RESECTION VS. OTHER), SURGICAL APPROACH (OPEN VS. VATS) AND TYPE OF LUNG RESECTION (ANATOMICAL VS. NON-ANATOMICAL) DURING THE INITIAL SURGERY; TYPE OF LUNG RESECTION (ANATOMICAL VS. NON-ANATOMICAL) DURING THE REDO PROCEDURE. POST OPERATIVE COMPLICATIONS INCLUDED: MEDIAN HOSPITAL LENGTH OF STAY WAS 5 (RANGE, 3¿24) DAYS, AND CHEST DRAINAGE LENGTH WAS 3 (RANGE, 1¿37) DAYS. COMPLICATIONS WERE OBSERVED IN SIXTEEN PATIENTS (42%), WITH THE MOST FREQUENT BEING PROLONGED AIR LEAK (>5 DAYS) IN 9 CASES (23.7%). PLEURAL EFFUSION DRAINAGE (1) PNEUMONIA (1), ATELECTASIS (2), ATRIAL FIBRILLATION (7), PULMONARY EMBOLISM (2) AND THE 30-DAY MORTALITY RATE WAS 0%. CONCLUSION REDO-VATS LUNG TUMOR RESECTION HAS BEEN DEMONSTRATED AS A SAFE AND FEASIBLE APPROACH WITH AN ACCEPTABLE CONVERSION RISK AND MORBIDITY. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND SOME REQUIRING MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059841 PROGEL PLATINUM PLUERAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H