BEUDAMED
    FDA Adverse Event Death Summary report: N

    PK PAPYRUS US 2.5/15

    MDR report key: 11790319 · Received May 7, 2021

    Report

    Report Number
    1028232-2021-02353
    Event Type
    Death
    Date Received
    May 7, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 12, 2021
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIV
    UDI-DI
    07640130447158
    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 AFFECTED 3 PK PAPYRUS STENT SYSTEMS WERE NOT RETURNED TO BIOTRONIK AND COULD THEREFORE NOT BE SUBJECTED TO A TECHNICAL INVESTIGATION. IMAGES OF THE CASE SUCH AS ANGIOGRAPHIES OR IVUS RECORDS COULD ALSO NOT BE OBTAINED. THE PROVIDED CLINICAL INFORMATION WAS INSUFFICIENT TO ESTABLISH WHETHER A DEVICE DEFICIENCY CONTRIBUTED TO THIS EVENT. HOWEVER, 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 INVESTIGATION NO DEVICE DEFICIENCY OR MANUFACTURING RELATED ROOT CAUSE COULD BE IDENTIFIED. 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 · 1

    DURING DIFFICULT PCI OF THE PROXIMAL RCA AND THE OSTIAL PDA, IVUS IMAGING CONFIRMED SEVERE DISEASE OF OSTIAL RCA. IVUS COULD NOT PASS BEYOND PDA OSTIUM. EVEN AFTER SEVERAL PRE-DILATATIONS A DES COULD NOT BE ADVANCED. SUBSEQUENTLY, A GUIDELINER WAS ATTEMPTED TO BE IMPLANTED BUT ALSO COULD NOT BE ADVANCED. IT WAS DECIDED TO IMPLANT A DES STENT IN THE OSTIAL RCA, WHICH WAS UNCOMPLICATED. AGAIN, AN ATTEMPT TO ADVANCE A GUIDELINER FAILED DESPITE MULTIPLE ATTEMPTS. THEN A STENT COULD BE ADVANCED INTO THE OSTIUM OF THE PDA. SHORTLY AFTER THIS A PERFORATION WAS NOTICED, WHICH WAS TREATED WITH A BALLOON TAMPONADE FIRST. A RIGHT FEMORAL ARTERY ACCESS WAS OBTAINED WITH A 3DRC CATHETER USING A PING-PONG TECHNIQUE. AFTERWARDS, IT WAS ATTEMPTED TO IMPLANT A 2.5/15 PK PAPYRUS BUT THE DEVICE COULD NOT BE ADVANCED AND THE STENT DISLODGED IN THE PROXIMAL RCA. A SECOND PK PAPYRUS STENT ALSO DISLODGED (REPORTED SEPARATELY). AN ACUTE OCCLUSION IN THE DISTAL RCA OCCURRED. THE GUIDE CATHETER IN THE WRIST APPEARED TO HAVE THROMBOSED AND WAS NO LONGER WORKING THEREFORE, ALL EQUIPMENT WAS REMOVED. PATIENT BEGAN TO HAVE BRADYCARDIA AND ELECTRICAL INSTABILITY. SINCE NOT EVEN A 1.2 MM BALLOON COULD PASS BEYOND THE OCCLUSION, AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED AND MEDICATION WAS GIVEN. BEFORE PATIENT COULD BE TRANSFERRING TO CICU, PATIENT HAD CARDIAC ARREST AND UNDERWENT CPR FOR 25 MINUTES. PATIENT PASSED AWAY IN CICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688385 PK PAPYRUS US 2.5/15 COVERED CORONARY STENT NIV BIOTRONIK AG, BUELACH, SWITZERLAND 434887 09195544 07640130447158

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death