BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT 5F VASCULAR STENT SYSTEM

    MDR report key: 16403662 · Received February 20, 2023

    Report

    Report Number
    9681442-2023-00037
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 24, 2023
    Report Date
    April 19, 2023
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    UDI-DI
    00801741120107
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO REPORT THAT MFR RPT# 9681442-2023-00037 WAS A DUPLICATE RECORD AND WAS OPENED IN ERROR. THE EVENT DETAILS ARE BEING CAPTURED UNDER COMPLAINT FILE # 7020270. H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. H10: D4 (EXPIRY DATE: 12/2023), G3. H11: SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE LIFESTENT 5F VASCULAR STENT SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319420 LIFESTENT 5F VASCULAR STENT SYSTEM VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANEZ2982 00801741120107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown