MAUDE Adverse Event Report: BIOTRONIK AG PK Papyrus US 3.0/26; Covered Coronary Stent System

Model Number	434899
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The pk papyrus covered stent system was selected for treatment of a lesion in the mid lad.The device was inserted into the patient's body but could not pass the lesion.The procedure was finished using a smaller pk papyrus.

• 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: jana burger ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 50469876
• Report Number: 8043892-2026-08122
• Device Sequence Number: 10172528
• Product Code: NIV
• UDI-Device Identifier: 07640130447271
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: H17004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 434899
• Device Lot Number: 01253453
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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
• Patient Sex: Unknown