BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 T3 6/200/135

    MDR report key: 12185334 · Received July 16, 2021

    Report

    Report Number
    1028232-2021-04028
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIP
    UDI-DI
    07640130447042
    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 INSTRUMENT 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. ONE PHOTOGRAPH TAKEN FROM THE ANGIOGRAM WAS PROVIDED. IT SHOWS AN INFLATED BALLOON WITH A LENGTH OF 200 MM INSIDE THE COMPLAINT STENT. THE FULLY RELEASED STENT APPEARS TO BE 40 MM SHORTER THAN THE BALLOON. UNFORTUNATELY, THE POOR QUALITY OF THE PHOTOGRAPH DOES NOT ALLOW ANY STATEMENT WITH REGARDS TO GEOMETRIC DISTORTIONS OF THE STENT STRUCTURE AND/OR INHOMOGENEOUS RADIOPACITY ALONG THE STENT LENGTH WHICH WOULD BE SUGGESTIVE OF FOCAL STENT COMPRESSION. DESPITE EXTENSIVE CORRESPONDENCE WITH THE LOCAL STAFF THE ORIGINAL ANGIOGRAPHIC MATERIAL COULD NOT BE OBTAINED. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE INSTRUMENT 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.

    Description of Event or Problem · 1

    A PULSAR-18 T3 6/200/135 PERIPHERAL STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT WAS DEPLOYED IN THE POLITEAL P1 AND SFA. HOWEVER, THE STENT SEEMS TO BE MUCH SHORTER THAN THE ACTUAL LENGTH WHICH IS DESCRIBED ON THE PACKAGING. THUS, A PASSEO-18 (6/200) WAS USED TO MEASURE THE STENT LENGTH AND THE STENT WAS FOUND TO BE ABOUT 40MM SHORTER THAT THE PASSEO-18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076408 PULSAR-18 T3 6/200/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG, BUELACH, SWITZERLAND 430506 10200784 07640130447042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown