BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 9721740 · Received February 18, 2020

    Report

    Report Number
    9681442-2020-00050
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    July 31, 2018
    Report Date
    February 18, 2020
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 510 K NUMBER AND PRO CODE FOR THE LIFESTENT SOLO VASCULAR STENT SYSTEM PRODUCTS ARE IDENTIFIED. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE 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 INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. JOURNAL ARTICLE CITATION: NAKAMURA, M., JAFF, M. R., SETTLAGE, R. A., KICHIKAWA, K., & INVESTIGATORS, R. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF ANNALS OF VASCULAR DISEASES TITLED " NITINOL SELF-EXPANDING STENTS FOR THE TREATMENT OF OBSTRUCTIVE SUPERFICIAL FEMORAL ARTERY DISEASE: THREE-YEAR RESULTS OF THE RELIABLE JAPANESE MULTICENTER STUDY " THAT AFTER STENT PLACEMENT, PRIMARY ENDPOINT ANALYSIS MENTIONED THAT RESTENOSIS WAS IDENTIFIED IN 6 PATIENTS. RESTENOSIS WAS ALSO IDENTIFIED IN A PATIENT WITH TYPE 4 STENT FRACTURE WHICH REQUIRED PLACEMENT OF TWO ADDITIONAL STENTS. TWELVE SERIOUS ADVERSE EVENTS RELATED TO THE DEVICE AND ONE RELATED TO THE PROCEDURE WERE CAUSED DUE TO PERIPHERAL VASCULAR RESTENOSIS. TARGET VESSEL REVASCULARIZATION WAS IDENTIFIED IN 7 PATIENTS THROUGH 12 MONTHS AND IN 14 PATIENTS THROUGH 36 MONTHS; SEVEN PATIENTS HAD AN ADDITIONAL STENT PLACED (11 STENTS) WHILE THE REMAINING PATIENTS RECEIVED REPEAT PTA OR ADDITIONAL ENDOVASCULAR THERAPY (E.G., LASER ATHERECTOMY). THE STATUS OF THE PATIENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183622 LIFESTENT SOLO VASCULAR STENT SYSTEM VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention