BEUDAMED
    FDA Adverse Event Death Summary report: N

    PK PAPYRUS US 3.5/15

    MDR report key: 12050608 · Received June 23, 2021

    Report

    Report Number
    1028232-2021-03516
    Event Type
    Death
    Date Received
    June 23, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIV
    UDI-DI
    07640130447172
    PMA / PMN Number
    H170004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INSTRUMENT WAS NOT 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 CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. DURING FINAL INSPECTION, EVERY STENT SYSTEM UNDERGOES VISUAL INSPECTION TO ENSURE CORRECT STENT EMBEDDING AND HOMOGENEOUS CRIMPING OF THE STENT. FURTHER, THE STENT OUTER DIAMETER IS VERIFIED TO 100 PERCENT. BASED ON THE CONDUCTED INVESTIGATIONS, NO MANUFACTURING OR MATERIAL RELATED ROOT CAUSE COULD BE IDENTIFIED. THE INSTRUMENT WAS INTENTIONALLY USED AFTER THE USE BY DATE WHICH IS WARNED AGAINST IN THE CORRESPONDING IFU.

    Description of Event or Problem · 1

    A PK PAPYRUS (PKP) COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION OF THE RCA. DUE TO GUIDE EXTENSION INTERACTION A 4.0/15 PKP COULD NOT BE ADVANCED. THEREFORE, THE AFFECTED PKP 3.5/15 WAS SELECTED. IT WAS CORRECTLY RECOGNIZED THAT THE PKP WAS EXPIRED BY 3 DAYS. GIVEN PATIENTS DETERIORATING HEMODYNAMICS DUE TO THE PERFORATION IT WAS DECIDED TO USE THE EXPIRED DEVICE, BUT THE REQUESTED PKP COULD ALSO NOT REACH THE LESION DUE TO GUIDE EXTENSION INTERACTION. THE GUIDE EXTENSION WAS REMOVED AND THE EXPIRED 3.5 X 15 PKP WAS ADVANCED TO THE PERFORATION AND SUCCESSFULLY DEPLOYED AND APPEARS TO HAVE SUCCESSFULLY SEALED THE PERFORATION. PATIENTS FAMILY WAS NOTIFIED POST PROCEDURE THAT AN EXPIRED DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945521 PK PAPYRUS US 3.5/15 COVERED CORONARY STENT NIV BIOTRONIK AG, BUELACH, SWITZERLAND 434889 05194081 07640130447172

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization