MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US 4.0/15; COVERED CORONARY STENT SYSTEM

Model Number	434890
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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.The provided clinical information (pk papyrus device registration form, cathlab report) and the production documentation were 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 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.Considering the event description, the most probable root cause for the reported event is related to the patient's anatomy (i.E.Previously implanted stent).The treating physician rated the occurrence as 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
A pk papyrus covered stent system was selected for treatment of a lesion in the distal rca with des during which a coronary artery perforation type ii occurred (perforation length 20 mm, reference vessel diameter 4.0 mm).To stop the bleeding, prolonged balloon inflation was performed, but still a persistent bleeding was detected.The affected pk papyrus was introduced into the patient's body but "the stent was caught on the proximal stent and dislodged from the balloon into the distal rca".The delivery system was withdrawn.After an unsuccessful snaring attempt, the dislodged stent was crushed against the vessel wall with a nc balloon and eventually over-stented with a pk papyrus 4.0/20 which sealed the perforation successfully.The treating physician rated the occurrence as device-related complication.

• Brand Name: PK PAPYRUS US 4.0/15
• 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: tina mueller ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22859233
• Report Number: 8043892-2025-08041
• Device Sequence Number: 13069052
• Product Code: NIV
• UDI-Device Identifier: 07640130447189
• UDI-Public: (01)07640130447189(17)261216(10)11244800
• 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): 08/21/2025

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: 434890
• Device Lot Number: 11244800
• 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: 08/04/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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