BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-ARMOR COVERED STENT

    MDR report key: 16184373 · Received January 17, 2023

    Report

    Report Number
    1318694-2023-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 17, 2023
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS A COMPASSIONATE USE DEVICE UNDER APPROVAL U220486. THE MARKETING APPROVAL FOR REGULAR SIZES IS P150028 - G-ARMOR COVERED STENT. THE COMPASSIONATE USE WAS FOR A DEVICE NOT INCLUDED IN THE MARKETING APPROVAL. IT WAS A LONGER G-ARMOR COVERED STENT (8.4CM) WITH ONLY A PARTIAL COVERING. THE DEVICE WAS NOT RETURNED TO NUMED FOR REVIEW AND INVESTIGATION. THE PRODUCTION TRAVELER (DHR) WAS REVIEWED AND NO ISSUES WERE FOUND. ALL DEVICES IN THIS LOT MET THE CRITERIA FOR RELEASE AND DISTRIBUTION. THERE ARE NO OTHER ASSOCIATED COMPLAINTS WITH THIS LOT OF DEVICES OR WITH THE ASSOCIATE COVERING COMPONENT. AS PER THE FOLLOW UP REPORT FROM THE PHYSICIAN THE PATIENT RETURNED TO PACU IN GOOD CONDITION. THERE WAS NO OBSERVABLE CLINICAL SYMPTOMS OR CHANGE IN SYMPTOMS IDENTIFIED WITH THE PATIENT NOTED IN THE REPORT. NO APPARENT HARM OCCURRED IN RELATION TO THE COVERING. AS NOTED IN THE REPORT FROM THE PHYSICIAN, THE INTRODUCER CHOSEN WAS NOT LONG ENOUGH TO GET TO THE LOCATION OF THE STENT PLACEMENT. THE PHYSICIAN ATTEMPTED TO PULL THE COVERED STENT BACK INTO INTRODUCER, WHICH IS A KNOWN RISK FOR COVERING DETACHMENTS. THERE IS A SPECIFIC WARNING IN THE INSTRUCTIONS FOR USE THAT STATES: "PULLING THE COVERED STENT BACK THROUGH THE INTRODUCER AND/OR HEMOSTASIS VALVE MAY CAUSE THE COVERING TO CATCH AND TEAR OFF OF THE STENT." USER FACILITY REPORT NUMBER WAS (B)(4). THE CATH. REPORT FROM THIS PROCEDURE IS BEING SENT TO THE FDA - CDRH - ODE AS PART OF THE COMPASSIONATE USE (U220486) FOLLOW-UP DOCUMENTATION. SO THIS WILL BE REPORTED TO THEM AS WELL. THIS WAS SENT VIA UPS ON 01/17/2023.

    Description of Event or Problem · 0

    STENT COVERING DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223637 G-ARMOR COVERED STENT AORTIC STENT PNF NUMED, INC. 432 EER-8881

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male