BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 T3 5/200/135

    MDR report key: 20258518 · Received September 19, 2024

    Report

    Report Number
    1028232-2024-04941
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 4, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIP
    UDI-DI
    07640130446946
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE AFFECTED DEVICE NOR THE ANGIOGRAPHIC MATERIAL WAS RETURNED. INSTEAD, TWO PHOTOGRAPHS TAKEN FROM THE ANGIOGRAM WERE PROVIDED. THE PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. THE PHOTOGRAPHS TAKEN FROM THE ANGIOGRAM SHOW THE TARGET VESSEL WITH NUMEROUS NARROWED ZONES ABOUT EIGHT WEEKS AFTER THE INITIAL PROCEDURE. THE STENT HAS FRACTURED INTO THREE PIECES. GEOMETRIC DISTORTIONS OF THE STENT STRUCTURE ARE VISIBLE. UNFORTUNATELY, NO ANGIOGRAPHIC MATERIAL OF THE BASELINE PROCEDURE COULD BE OBTAINED. THE PHOTOGRAPHS PROVIDED DO NOT CONTAIN FURTHER RELEVANT INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. BASED ON THE CONDUCTED INVESTIGATIONS, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED. PLEASE NOTE THAT, ACCORDING TO THE IFU, FRACTURES OF NITINOL STENTS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY HAVE BEEN REPORTED IN MEDICAL LITERATURE. FRACTURES OCCURRED MORE FREQUENTLY AND WERE MORE SEVERE IN LONG STENTED SEGMENTS AND IN THE CASE OF MULTIPLE, PARTIALLY OVERLAPPING STENTS. THESE FRACTURES WERE FREQUENTLY ASSOCIATED WITH RESTENOSIS OR OCCLUSION OF THE ARTERY.

    Description of Event or Problem · 0

    THE PULSAR-18 T3 PERIPHERAL SELF-EXPANDABLE STENT WAS IMPLANTED ON (B)(6) 2024. APPROXIMATELY 7 WEEKS LATER THE PATIENT RETURNED ON (B)(6) 2024 WITH RECURRING SYMPTOMS. UPON FLUOROSCOPIC EXAM THE VESSEL WAS NOTED TO BE RENARROWED AND THE STENT FRACTURED INTO TYPE 3 STENT FRACTURES AND WAS NOTED TO BE SEPARATED INTO 3 PIECES, WITH AREAS OF TYPE 1 ALSO EVIDENT. ANOTHER STENT WAS PLACED ON (B)(6) 2024 AND THIS PULSAR REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504003 PULSAR-18 T3 5/200/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG, BUELACH, SWITZERLAND 430496 01243388 07640130446946

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization