BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 9940028 · Received April 8, 2020

    Report

    Report Number
    9681442-2020-00081
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Report Date
    July 26, 2022
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    UDI-DI
    00801741110399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED; THEREFORE, A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR 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 LIFESTENT SOLO VASCULAR STENT SYSTEM 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. ANN VASC DIS VOL. 11, NO. 3; 2018; PP 324¿334. DOI: 10.3400/AVD.OA.18-00067. H10: G3, H6(DEVICE). H11: B5, G1, H6(CONCLUSION). H11:SECTION A THROUGH F - 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. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX061703JL VASCULAR STENT EXPERIENCED MALPOSITION OF THE DEVICE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE 76 YEAR OLD MALE PATIENT WAS 72 KGS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED; THEREFORE, A LOT HISTORY REVIEW IS CURRENTLY BEING PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR REVIEW. 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 LIFESTENT SOLO VASCULAR STENT SYSTEM PRODUCTS IS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX061703JL VASCULAR STENT EXPERIENCED MALPOSITION OF THE DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399292 LIFESTENT SOLO VASCULAR STENT SYSTEM VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXA4030 00801741110399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown