BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK PAPYRUS US 3.0/15

    MDR report key: 17325561 · Received July 14, 2023

    Report

    Report Number
    1028232-2023-03531
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 17, 2023
    Report Date
    August 21, 2023
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIV
    UDI-DI
    07640130447165
    PMA / PMN Number
    H170004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 PRODUCT RELEASE DOCUMENTATION WERE REVIEWED TO ESTABLISH WHETHER A DEVICE DEFICIENCY CONTRIBUTED TO THIS EVENT. REVIEW OF THE PRODUCT RELEASE 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 BOTH NO DEVICE- AND NO PROCEDURE-RELATED COMPLICATION. 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 (PKP) WERE SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE MID LAD. THE FIRST PKP WAS ATTEMPTED TO BE INTRODUCED WITH THE HELP OF A GUIDELINER DEVICE. SEVERAL ATTEMPTS WERE UNSUCCESSFUL. THE PKP WAS PULLED BACK IN GUIDELINER AND RESISTANCE WAS FELT, SO EVERYTHING WAS TAKEN OUT TOGETHER. WHEN ALL WAS BACK ON THE TABLE, IT WAS ATTEMPTED TO USE A NEW GUIDELINER BUT THE SAME PKP. DURING REMOVAL OF THE PKP FROM GUIDELINER BACK ON TABLE, THE PKP DELIVERY SYSTEM CAME OUT, BUT THE STENT STAYED INSIDE THE GUIDELINER. A NEW GUIDELINER WAS USED, AND IT WAS PROCEEDED TO BALLOONING THE PERFORATION SITE SEVERAL TIMES. THEN A NEW PKP (2ND) WAS USED AND WAS SUCCESSFULLY DELIVERED, BUT FURTHER BLEEDING WAS DETECTED. A 3RD PK PAPYRUS WAS INTRODUCED BUT COULD NOT CROSS AND WAS THEREFORE WITHDRAWN. THE BLEEDING WAS THEN TREATED WITH PROLONGED BALLOON INFLATION. AT THAT TIME THE BLEEDING STOPPED, AND THE PERFORATION WAS SUCCESSFULLY SEALED. PATIENT IS FINE AND HAS RECOVERED. THIS REFERS TO THE 3RD PK PAPYRUS. THE OTHER TWO PKPS ARE REPORTED SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654650 PK PAPYRUS US 3.0/15 COVERED CORONARY STENT NIV BIOTRONIK AG, BUELACH, SWITZERLAND 434888 01222037 07640130447165

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female