BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 14359376 · Received May 11, 2022

    Report

    Report Number
    3004962788-2022-00034
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    August 20, 2021
    Report Date
    May 11, 2022
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: THERMAL ABLATION VERSUS STEREOTACTIC ABLATIVE BODY RADIOTHERAPY TO TREAT UNRESECTABLE COLORECTAL LIVER METASTASES: A COMPARATIVE ANALYSIS FROM THE PROSPECTIVE AMSTERDAM CORE REGISTRY SOURCE: CANCERS 2021, 13, 4303. HTTPS://DOI.ORG/10.3390/CANCERS13174303 H6 PATIENT CODES: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY BETWEEN JANUARY 2007 AND AUGUST 2020 ANALYZED OUTCOMES OF 144 PATIENTS WITH COLORECTAL LIVER METASTASES (CRLM) WHO UNDERWENT EITHER THERMAL ABLATION OR STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR). THERMAL ABLATION WAS PERFORMED WITH EITHER RADIOFREQUENCY ABLATION (RFA) OR MICROWAVE ABLATION (MWA). RFA WAS PERFORMED WITH COMPETITOR DEVICES AND MWA WAS PERFORMED WITH EITHER THE EMPRINT SYSTEM OR A COMPETITOR DEVICE. REPORTED COMPLICATIONS ASSOCIATED WITH MWA INCLUDED: BILE LEAKAGE REQUIRING PERCUTANEOUS DRAINAGE, INTRAHEPATIC ABSCESS REQUIRING PERCUTANEOUS DRAINAGE, HEPATIC HEMORRHAGE REQUIRING COIL EMBOLIZATION, BACTEREMIA WITH NO INFORMATION REGARDING INTERVENTIONS, INTRAOPERATIVE STOMACH PERFORATION WITH NO INFORMATION REQUIRING INTERVENTIONS, ABSCESS REQUIRING ANTIBIOTICS, HEMATOMA WITH NO INFORMATION REGARDING INTERVENTIONS AND PNEUMOTHORAX REQUIRING NO INTERV ENTION. THE ARTICLE DOES NOT SPECIFY WHICH DEVICE IS ASSOCIATED WITH THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998310 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other