BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18869323 · Received March 8, 2024

    Report

    Report Number
    2210968-2024-02770
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    July 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED H6 CLINICAL CODE: E2402 ¿ VENOUS CONDUIT OCCLUDED, ASCITES CITATION: ANN SURG 2023;278:E94¿E104; DOI: 10.1097/SLA.0000000000005575 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: LAPARO-ENDOSCOPIC SINGLE-SITE VERSUS CONVENTIONAL LAPAROSCOPIC SURGERY FOR EARLY-STAGE ENDOMETRIAL CANCER: A RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL THIS STUDY ANALYZED SUCCESSES AND FAILURES OF PUSHING THE BOUNDARIES IN VASCULAR PANCREATIC SURGERY TO ESTABLISH SAFETY OF CONDUIT RECONSTRUCTIONS. BETWEEN OCTOBER 2013 AND JULY 2020, 63 IMPLANTED CONDUITS IN 56 PANCREATIC RESECTIONS OF HIGHLY SELECTED CANCER PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 34 MALES AND 22 FEMALES WITH A MEDIAN AGE OF 65.2 YEARS (RANGE, 40.4¿80.8). MEDIAN BODY MASS INDEX WAS 25 KG/M2. ALL PATIENTS HAD AN UNDERLYING ONCOLOGIC DISEASE, WITH THE MAIN INDICATION FOR SURGERY BEING DUCTAL ADENOCARCINOMA IN 50 PATIENTS (IN ADDITION TO PANCREATIC NEUROENDOCRINE TUMORS IN 5 PATIENTS AND 1 PATIENT WITH LEIOMYOSARCOMA). FOR VASCULAR RECONSTRUCTION, 25 ARTERIAL AND 38 VENOUS CONDUITS WERE UTILIZED DURING 39 PANCREATODUODENECTOMIES, 14 DISTAL PANCREATECTOMIES, AND 3 TOTAL PANCREATECTOMIES. GRAFT USED WERE AUTOLOGOUS GRAFTS FROM GREATER SAPHENOUS VEIN IN 26 PATIENTS, CRYOPRESERVED ALLOGENEIC VASCULAR GRAFTS (MANUFACTURER: CRYOLIFE INC.) IN 23 PATIENTS, SYNTHETIC GRAFTS (MANUFACTURER: W.L. GORE & ASSOCIATES INC.) IN 11 PATIENTS ,AND BOVINE PERICARDIAL PATCHES (MANUFACTURER: LEMAITRE VASCULAR INC.) THAT WERE TUBULARIZED WITH A RUNNING 5-0 PROLENE SUTURE (ETHICON) OR SURGICAL LINEAR STAPLER DEVICE (MANUFACTURER: UNKNOWN) IN 3 PATIENTS. POSTOPERATIVELY, INDEPENDENT OF A RECONSTRUCTION IN THE ARTERIAL OR VENOUS SYSTEM, LIFE-LONG ASPIRIN 325 MG WAS PRESCRIBED (FIRST CHOICE) OR ASPIRIN 81 MG, DEPENDENT ON CASE-SPECIFIC RISKS OF POSTPANCREATECTOMY HEMORRHAGE OR PATIENT-SPECIFIC CONTRAINDICATIONS. REPORTED COMPLICATIONS INCLUDED PATIENT 2, VENOUS CONDUIT OCCLUDED ON POSTOPERATIVE DAY (N=?), OCCLUDED VENOUS CONDUITS CAUSING PORTAL HYPERTENSION AND ASCITES (N=?). IN CONCLUSION, OUR PERIOPERATIVE MORTALITY OF VASCULAR PANCREATIC SURGERY WITH CONDUITS IN THE ARTERIAL OR VENOUS SYSTEM IS 9 PERCENT. RECONSTRUCTIONS ARE TECHNICALLY FEASIBLE WITH DIFFERENT ANATOMIC AND EXTRA-ANATOMIC STRATEGIES, WHILE IDENTIFYING PREDICTORS OF EARLY CONDUIT OCCLUSION REMAINS CHALLENGING. OPTIMIZING RECONSTRUCTED ARTERIAL AND VENOUS HEMODYNAMICS IN THE CONTEXT OF PANCREATIC MALIGNANCY WILL ENABLE LONG-TERM SURVIVAL IN MORE PATIENTS RESPONSIVE TO CHEMOTHERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680449 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention