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	10/01/2025
Type of Reportable Event	Malfunction
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.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 conducted review, no 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.
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of a severely calcified lesion in the lm to proximal lad (no further information available) by orbital atherectomy during which a coronary artery perforation occurred.The orbital atherectomy wire sheared in half with the distal portion of the wire remaining in the mid to distal lad.The two affected pk papyrus (the 1st device was reported separately) were introduced into the patient's body but could not cross the lesion.

• 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: 23727004
• Report Number: 8043892-2025-11143
• Device Sequence Number: 10629083
• Product Code: NIV
• UDI-Device Identifier: 07640130447271
• UDI-Public: (01)07640130447271(17)270325(10)03251164
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/05/2025

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: 03251164
• 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: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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