BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK PAPYRUS 2.5/15

    MDR report key: 17135580 · Received June 15, 2023

    Report

    Report Number
    1028232-2023-03011
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 31, 2023
    Report Date
    August 2, 2023
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIV
    UDI-DI
    07640130416413
    PMA / PMN Number
    H17004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT WAS SUBJECTED TO A DETAILED TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCT RELEASE DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THIS EVENT. THE TECHNICAL INVESTIGATION REVEALED THAT THE BALLOON HAS BEEN INFLATED AND WAS RETURNED IN A PARTIALLY DEFLATED STATE. MICROSCOPIC ANALYSIS SHOWED STENT IMPRINTS ON THE EXPOSED BALLOON SURFACE, INDICATING THAT THE STENT WAS CRIMPED IN BETWEEN THE TWO RADIOPAQUE MARKERS AT THE TIME OF DELIVERY. THE STENT WAS RETURNED STILL ON THE BALLOON CATHETER WITH WHICH IT WAS RETRIEVED FROM THE PATIENT. THE STENT IS SEVERELY DEFORMED AT THE DISTAL END, I.E., SEVERAL STRUTS ARE EVERTED, AND THE STENT IS PARTIALLY EXPANDED. REVIEW OF THE PRODUCT RELEASE DOCUMENTATION CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. AS A PART OF FINAL INSPECTION EVERY STENT SYSTEM UNDERGOES VISUAL INSPECTION TO ENSURE CORRECT EMBEDDING AND HOMOGENEOUS CRIMPING OF THE STENT. FURTHER, THE STENT OUTER DIAMETER IS VERIFIED TO 100 PERCENT AND THE STENT RETENTION FORCE OF A DEFINED AMOUNT OF SAMPLES IS TESTED FROM EVERY LOT. BASED ON THE CONDUCTED INVESTIGATIONS, NO MANUFACTURING OR MATERIAL RELATE ROOT CAUSE WAS DETERMINED. PK PAPYRUS IS INDICATED FOR THE TREATMENT OF ACUTE CORONARY ARTERY PERFORATIONS. 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

    A PK PAPYRUS COVERED STENT SYSTEM (PKP) WAS SELECTED FOR TREATMENT. DURING TREATMENT OF A HIGH-GRADE CALCIFIED LESION WITH ROTABLATOR AND STENT, A VASCULAR RUPTURE WAS DETECTED ON ANGIOGRAPHY. A RYUSEI BALLOON WAS USED TO STOP THE BLEEDING. THEN THE PKP WAS INSERTED AND INFLATED UP TO 12 ATM, BUT AFTER POST-DILATATION WITH A NC BALLOON, THE PREVIOUSLY EXPANDED PKP STENT WAS MOUNTED ON THE BALLOON. ANOTHER COVERED STENT WAS ATTEMPTED TO BE USED BUT COULD NOT BE DELIVERED. SINCE THERE WAS NO COVERED STENT, IT WAS ORDERED FROM ANOTHER FACILITY AND PKP 3.0/15 WAS SUCCESSFULLY PLACED. ALTHOUGH HEMOSTASIS WAS SUCCESSFUL IN THE PART WHERE THE BLOOD LEAKED, THERE WAS A BLOOD LEAK IN THE DISTAL PART, AND TWO PKPS WERE OVERLAPPED WITH THE PREVIOUSLY PLACED PKP. SUCCEEDED IN STOPPING BLEEDING. LATER, IT WAS UNDERSTOOD THAT THE EXPANSION HAD BEEN PERFORMED WITHOUT NOTICING THAT THE PKP 2.5/15MM HAD FALLEN OFF THE FIRST TIME. THE DROPPED PKP WAS ON THE GW RAIL, WAS ACCIDENTALLY MOUNTED ON THE NC BALLOON, WAS USED FOR ADDITIONAL EXPANSION, AND WAS ABLE TO BE REMOVED FROM THE BODY AND RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057636 PK PAPYRUS 2.5/15 COVERED CORONARY STENT SYSTEM NIV BIOTRONIK AG, BUELACH, SWITZERLAND 369380 09224418 07640130416413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown