MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US 3.0/26; COVERED CORONARY STENT SYSTEM

Model Number	434899
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, discharge summary) and the production documentation were reviewed to establish whether a device deficiency contributed to the event.Review of the production 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 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
It was intended to treat a lesion in the mid lad with a balloon during which a coronary artery perforation type ii (perforation length 18 mm) occurred.The pk papyrus covered stent was successfully implanted with 13 atm.However, ivus demonstrated an inadequately apposed stent which was then post-dilated with two nc balloon.In addition, an onyx stent was implanted in the proximal lad overlapping the pk papyrus.Post-dilation was again performed with an nc mm balloon.Subsequent angiography revealed a small distal stent edge dissection distal to the covered stent which was treated with an onyx stent which was again implanted in an overlapping manner.Final angiography showed post-procedural timi-3 flow with no compromise of side branches and small distal wire perforation that resolved with repeated angiography.

• Brand Name: PK PAPYRUS US 3.0/26
• 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: tina mueller ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22949553
• Report Number: 8043892-2025-08146
• Device Sequence Number: 15850880
• Product Code: NIV
• UDI-Device Identifier: 07640130447271
• UDI-Public: (01)07640130447271(17)260401(10)03240984
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: H17004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/03/2025

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: 04/01/2026
• Device Model Number: 434899
• Device Lot Number: 03240984
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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: Required Intervention
• Patient Sex: Unknown