BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 6/120/135

    MDR report key: 18410241 · Received December 28, 2023

    Report

    Report Number
    1028232-2023-06489
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 11, 2023
    Report Date
    February 29, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIP
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE COMPLAINT PRODUCT NOR THE ANGIOGRAPHIC MATERIAL WAS RETURNED FOR ANALYSIS. THEREFORE, NO TECHNICAL INVESTIGATION ON THE SUBJECT COULD BE PERFORMED. THE PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE PRODUCT DETAILED ABOVE VERIFIED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 0

    11-JAN-2024 ADDITIONAL INFORMATION: THE COMPLAINT PRODUCT WAS POSITIONED IN THE TARGET LESION. THE PHYSICIAN STARTED TO RELEASE THE STENT AND DIFFICULTIES DURING STENT RELEASE WERE EXPERIENCED. 23-FEB-2024 INITIALLY, LOT 02235432 (PULSAR-18 6/120/135) WAS REPORTED FOR THIS REPORT, (B)(4). LOT 07232923 (PULSAR-18 5/150/135) WAS REPORTED ON (B)(4). AFTER THE TECHNICAL INVESTIGATION OF THE TWO RETURNED PRODUCTS AND ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, IT WAS CONFIRMED THAT THE LOT NUMBERS WERE ACCIDENTALLY MIXED-UP. THIS REPORT, (B)(4) SHOULD BE LOT 07232923 (PULSAR-18 5/150/135) THE RETURNED PRODUCT WAS SUBJECTED TO A DETAILED TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. THE AFFECTED DEVICE WAS RETURNED COMPLETELY DISASSEMBLED WITH ONE SINGLE PART MISSING. THE STENT HAS BEEN FULLY RELEASED. THE OUTER SHAFT HAS BEEN RETRACTED BY ABOUT 323 MM. THE SHAFT IS KINKED AT FOUR DIFFERENT LOCATIONS. STENT IMPRINTS ARE VISIBLE OVER A LENGTH OF ABOUT 150 MM, INDICATING THAT THE STENT WAS PROPERLY CRIMPED UNDER THE OUTER SHAFT AT THE TIME OF DELIVERY. ALL DIMENSIONS OF ALL PARTS ARE WITHIN SPECIFICATION. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 0

    11-JAN-2024 ADDITIONAL INFORMATION: THE COMPLAINT PRODUCT WAS POSITIONED IN THE TARGET LESION. THE PHYSICIAN STARTED TO RELEASE THE STENT AND DIFFICULTIES DURING STENT RELEASE WERE EXPERIENCED. NEITHER THE COMPLAINT PRODUCT NOR THE ANGIOGRAPHIC MATERIAL WAS RETURNED FOR ANALYSIS. THEREFORE, NO TECHNICAL INVESTIGATION ON THE SUBJECT COULD BE PERFORMED. THE PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE PRODUCT DETAILED ABOVE VERIFIED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE WAS DETERMINED.

    Description of Event or Problem · 0

    A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH 70 PERCENT STENOSIS DEGREE. DURING THE PROCEDURE, WHEN THE PHYSICIAN RELEASED THE STENT, THE STENT MOVED FORWARD AND COULD NOT COVER ALL OF THE LESION. HE USED ANOTHER STENT TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360136 PULSAR-18 6/120/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG, BUELACH, SWITZERLAND 366839 02235432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown