BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 9955594 · Received April 13, 2020

    Report

    Report Number
    9681442-2020-00101
    Event Type
    Malfunction
    Date Received
    April 13, 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 NUMBERS FOR THE TWO MALFUNCTIONS WERE PROVIDED AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE INVESTIGATIONS ARE INCONCLUSIVE FOR FRACTURE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE 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. NAKAMURA, M., JAFF, M. R., SETTLAGE, R. A., KICHIKAWA, K (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. H11: 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 TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX061703JL VASCULAR STENT ALLEGEDLY EXPERIENCED FRACTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. ONE PATIENT WAS REPORTED AS A 69-YEAR-OLD FEMALE WEIGHING 64 KGS; ANOTHER PATIENT WAS REPORTED AS A 76-YEAR-OLD MALE WEIGHING 72 KGS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS FOR THE TWO MALFUNCTIONS WERE PROVIDED AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE INVESTIGATIONS ARE INCONCLUSIVE FOR FRACTURE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE 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 TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX061703JL VASCULAR STENT ALLEGEDLY EXPERIENCED FRACTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. ONE PATIENT WAS REPORTED AS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) KGS; THE OTHER PATIENTS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417949 LIFESTENT SOLO VASCULAR STENT SYSTEM VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXA4030 00801741110399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown