MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US 2.5/15; COVERED CORONARY STENT SYSTEM,

Model Number	434887
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent was selected for treatment.It was reported that the stent wire snapped in two parts while trying to cross over.
Event or Problem Description
A pk papyrus covered stent was selected for treatment.It was reported that the stent wire snapped in two parts while trying to cross over.Additional information received: during orbital atherectomy of a heavily calcified lm-proximal lad lesion, a coronary perforation occurred and the atherectomy wire sheared, leaving its distal portion in the lad.Two pk papyrus devices (cpids 25111402 & 25111403) could not cross the lesion.During a further attempt, the pk papyrus hypotube fractured outside the patient's body, with no resistance reported during insertion.
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.

• Brand Name: PK PAPYRUS US 2.5/15
• 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: 23308236
• Report Number: 8043892-2025-10031
• Device Sequence Number: 5788634
• Product Code: NIV
• UDI-Device Identifier: 07640130447158
• UDI-Public: (01)07640130447158(17)260911(10)08240476
• 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,Followup
• Report Date (Section B): 12/09/2025

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 Expiration Date: 09/11/2026
• Device Model Number: 434887
• Device Lot Number: 08240476
• 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: 10/16/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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
• Patient Sex: Unknown