MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US; COVERED CORONARY STENT SYSTEM

Model Number	434901
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Multiple Organ Dysfunction Syndrome (3261)
Date of Event	09/25/2025
Type of Reportable Event	Death
Event or Problem Description
After placing the pk papyrus covered stent system in the mid rca, there was a "haziness" in the distal stent with st elevations but ivus interestingly did not show clear evidence of thrombus.However, within a few minutes the vessel shut down.After ballooning it was possible to restore flow, but again, the vessel shut down and appeared to show thrombus.It may have all been rv failure with no reflow.The patient was transferred to icu and expired two days after procedure from multiorgan failure.The device was used after the expiration date.
Additional Manufacturer Narrative
The affected pk papyrus stent system was not returned 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) was reviewed to establish whether a device deficiency contributed to this event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The treating physician rated the occurrence as no procedure- but device-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.
Event or Problem Description
After placing the pk papyrus covered stent system in the mid rca, there was a "haziness" in the distal stent with st elevations but ivus interestingly did not show clear evidence of thrombus.However, within a few minutes the vessel shut down.After ballooning it was possible to restore flow, but again, the vessel shut down and appeared to show thrombus.It may have all been rv failure with no reflow.The patient was transferred to icu and expired two days after procedure from multiorgan failure.The device was used after the expiration date.

• Brand Name: PK PAPYRUS US
• Common Device Name: COVERED CORONARY STENT SYSTEM
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 23424262
• Report Number: 8043892-2025-10035
• Device Sequence Number: 9799038
• Product Code: NIV
• UDI-Device Identifier: 07640130447295
• UDI-Public: (01)07640130447295(17)250918(10)08234552
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: H17004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2025
• Device Model Number: 434901
• Device Lot Number: 08234552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown