BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELLIS-6 PERIPHERAL INFUSION SYSTEM

    MDR report key: 18372690 · Received December 21, 2023

    Report

    Report Number
    2183870-2023-00460
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    January 17, 2021
    Report Date
    December 21, 2023
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    PMA / PMN Number
    K130904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE: IMAGE-GUIDED PERCUTANEOUS THERMAL ABLATION OF OLIGOMETASTATIC OVARIAN AND NON-OVARIAN GYNECOLOGIC TUMORS J VASC INTERV RADIOL 2021; 32:729¿738 HTTPS://DOI.ORG/10.1016/J.JVIR.2021.01.270 B3: DATE OF ACCEPTANCE 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

    PURPOSE: TO ASSESS THE SAFETY, FEASIBILITY, AND EFFICACY OF PERCUTANEOUS THERMAL ABLATION (TA) IN THE TREATMENT OF METASTATIC GYNECOLOGIC (GYN) TUMORS. MATERIALS AND METHODS: A STUDY COHORT OF 42 CONSECUTIVE WOMEN (MEAN AGE, 59. YEARS; RANGE, 25¿78 YEARS) WITH METASTATIC GYN TUMORS (119 METASTATIC TUMORS) TREATED WITH RADIOFREQUENCY (N ¼ 47 TUMORS), MICROWAVE (N ¼ 47 TUMORS), OR CRYOGENIC (N ¼ 30 TUMORS) ABLATION FROM OVER 2,800 ABLATIONS PERFORMED FROM JANUARY 2001 TO JANUARY 2019 WAS IDENTIFIED. THE PRIMARY GYN NEOPLASMS CONSISTED OF OVARIAN (27 PATIENTS; 77 TUMORS; MEAN TUMOR DIAMETER [MTD], 2.50 CM), UTERINE (7 PATIENTS; 26 TUMORS; MTD, 1.89 CM), ENDOMETRIAL (5 PATIENTS; 10 TUMORS; MTD, 2.8 CM), VAGINAL (2 PATIENTS; 5 TUMORS; MTD, 2.40 CM), AND CERVICAL (1 PATIENT; 1 TUMOR; MTD, 1.90 CM) CANCERS. IN ORDER OF DESCENDING FREQUENCY, METASTATIC TUMORS TREATED BY TA WERE LOCATED IN THE LIVER OR LIVER CAPSULE (74%), LUNGS (13%), AND PERITONEAL IMPLANTS (9%). SINGLE TUMORS WERE ALSO TREATED IN THE KIDNEYS, RECTUS MUSCLE, PERIRECTAL SOFT TISSUE (2.5%), AND RETROPERITONEAL LYMPH NODES (1.6%). ALL EFFICACY PARAMETERS OF TA AND DEFINITIONS OF MAJOR AND MINOR ADVERSE EVENTS ARE CATEGORIZED BY THE LATEST SOCIETY OF INTERVENTIONAL RADIOLOGY REPORTING STANDARDS. RESULTS: THE MEDIAN FOLLOW-UP OF TREATED PATIENTS WAS 10 MONTHS. AFTER THE INITIAL ABLATION, 95.6% OF THE PATIENTS ACHIEVED A COMPLETE TUMOR RESPONSE CONFIRMED BY CONTRAST-ENHANCED MAGNETIC RESONANCE IMAGING OR COMPUTED TOMOGRAPHY. ON SURVEILLANCE IMAGING, 8.5% OF THE ABLATED TUMORS DEVELOPED LOCAL PROGRESSION OVER A MEDIAN FOLLOW-UP PERIOD OF 4.1 MONTHS. FIVE OF 8 TUMORS WITH LOCAL RECURRENCE UNDERWENT REPEATED TREATMENT OVER A MEAN FOLLOW-UP PERIOD OF 18 MONTHS, AND 4 OF 5 TUMORS ACHIEVED COMPLETE ERADICATION AFTER 1 ADDITIONAL TREATMENT SESSION THAT RESULTED IN A SECONDARY EFFICACY OF 80%. THE OVERALL TECHNIQUE EFFICACY OF TA WAS 96.2% OVER A MEDIAN FOLLOW-UP PERIOD OF 10 MONTHS. CONCLUSIONS: TA WAS SAFE AND EFFECTIVE FOR THE LOCAL CONTROL OF METASTATIC GYN TUMORS IN THE LUNGS, ABDOMEN, AND PELVIS, WITH AN OVERALL SURVIVAL RATE OF 37.5 MONTHS AND A LOCAL PROGRESSION-FREE SURVIVAL RATE OF 16.5 MONTHS, WITH ONLY 4.8% OF TREATED PATIENTS EXPERIENCING A MAJOR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297073 TRELLIS-6 PERIPHERAL INFUSION SYSTEM CATHETER, CONTINUOUS FLUSH KRA COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention