BEUDAMED
    FDA Adverse Event Death Summary report: N

    PK PAPYRUS US 3.0/15

    MDR report key: 22044301 · Received May 19, 2025

    Report

    Report Number
    1028232-2025-02437
    Event Type
    Death
    Date Received
    May 19, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 18, 2025
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIV
    UDI-DI
    07640130447165
    PMA / PMN Number
    H170004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PK PAPYRUS STENT SYSTEM WAS NOT RETURNED TO BIOTRONIK AND COULD THEREFORE NOT BE SUBJECTED TO A TECHNICAL INVESTIGATION. IMAGES OF THE CASE SUCH AS ANGIOGRAPHIES COULD ALSO NOT BE OBTAINED. THE PROVIDED CLINICAL INFORMATION (PK PAPYRUS DEVICE REGISTRATION FORM, CATHLAB REPORT) AND THE PRODUCTION DOCUMENTATION WERE REVIEWED TO ESTABLISH WHETHER A DEVICE DEFICIENCY CONTRIBUTED TO THE EVENT. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. BASED ON THE PROVIDED DOCUMENTATION AND THE CONDUCTED REVIEW, NO MANUFACTURING RELATED ROOT CAUSE COULD BE IDENTIFIED. THE TREATING PHYSICIAN RATED THE OUTCOME AS NO DEVICE- BUT PROCEDURE-RELATED COMPLICATION. IT SHOULD BE NOTED THAT THE IFU ADVISES THE USER TO SELECT THE STENT SIZE TO MATCH THE DIAMETER OF THE VESSEL TO ACHIEVE A FINAL STENT DIAMETER TO VESSEL RATIO OF 1:1. PK PAPYRUS IS INDICATED FOR THE TREATMENT OF ACUTE PERFORATIONS OF NATIVE CORONARY ARTERIES AND CORONARY BYPASS GRAFTS IN VESSELS 2.5 TO 5.0 MM IN DIAMETER. AS SUCH, THIS DEVICE IS TYPICALLY USED IN EMERGENT RESPONSE TO A LIFE-THREATENING ADVERSE PROCEDURAL EVENT UNRELATED TO USE OF THE PK PAPYRUS.

    Description of Event or Problem · 0

    PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION (15 MM LENGTH) OCCURRED DURING POST-DILATATION OF A DES. AFTER THE FIRST PK PAPYRUS (COMPLAINT DEVICE) WAS PLACED, THE PERFORATION WAS NOT COMPLETELY SEALED SO A SECOND PK PAPYRUS WAS DEPLOYED. A POSSIBLE EDGE DISSECTION AT THE EDGE OF THE SECOND STENT SUSPECTED (REPORTED SEPARATELY), SO AN ONYX FRONTIER WAS DEPLOYED. AFTERWARDS, AN IMPELLA WAS PLACED AND THE PATIENT LEFT CATH LAB TO ICU. PATIENT CONTINUED TO HAVE SEVERE HEMODYNAMIC COMPROMISE DESPITE INCREASING MECHANICAL SUPPORT. FAMILY ULTIMATELY DECIDED TO WITHDRAW CARE. ADDITIONAL PATIENT CODE E0504.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142974 PK PAPYRUS US 3.0/15 COVERED CORONARY STENT NIV BIOTRONIK AG, BUELACH, SWITZERLAND 434888 12230093 07640130447165

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death