BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 9941540 · Received April 8, 2020

    Report

    Report Number
    9681442-2020-00091
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Report Date
    July 23, 2022
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    UDI-DI
    00801741110436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WAS PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE LIFESTENT SOLO VASCULAR STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE FOR THE PRODUCTS IS IDENTIFIED IN D2. MASATO NAKAMURA, MICHAEL R. JAFF, RICHARD A. SETTLAGE, AND KIMIHIKO KICHIKAWA (2018). NITINOL SELF-EXPANDING STENTS FOR THE TREATMENT OF OBSTRUCTIVE SUPERFICIAL FEMORAL ARTERY DISEASE: THREE-YEAR RESULTS OF THE RELIABLE JAPANESE MULTICENTER STUDY. ANNALS OF VASCULAR DISEASES, 11(3), 324¿334. DOI: 10.3400/AVD.OA.18-00067. THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. THE MALFUNCTION WAS REVIEWED AND INDICATED THAT MODEL EX070603JL VASCULAR STENT ALLEGEDLY EXPERIENCED A FRACTURE. THIS MALFUNCTION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 86 YEARS OLD MALE PATIENT WEIGHT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WAS PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE LIFESTENT SOLO VASCULAR STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE FOR THE PRODUCTS IS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. THE MALFUNCTION WAS REVIEWED AND INDICATED THAT MODEL EX070603JL VASCULAR STENT ALLEGEDLY EXPERIENCED A FRACTURE. THIS MALFUNCTION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. PATIENT AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398673 LIFESTENT SOLO VASCULAR STENT SYSTEM VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWJ0769 00801741110436

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown