MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US 3.0/15; COVERED CORONARY STENT SYSTEM

Model Number	434888
Medical Device Problem Codes	Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent system was selected for treatment.After insertion of the pk papyrus the patient began to code, and the device could not be delivered as it was necessary to perform 3 rounds of cpr.Upon withdrawal, it seemed like the cover came off the stent system.Ivus was performed but the cover could not be located.Thus, the lesion was ballooned again in case the cover had been left inside the lesion to trap it against the vessel wall.
Event or Problem Description
A pk papyrus covered stent system was selected for treatment.After insertion of the pk papyrus the patient began to code, and the device could not be delivered as it was necessary to perform 3 rounds of cpr.Upon withdrawal, it seemed like the cover came off the stent system.Ivus was performed but the cover could not be located.Thus, the lesion was ballooned again in case the cover had been left inside the lesion to trap it against the vessel wall.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the stent is severely deformed at its proximal end, i.E., one stent strut is strongly bent outwards.Outside of the deformed zone, the crimped diameter of the stent still complies with the specification.The stent imprint on the exposed balloon surface indicate that the deformed strut was initially crimped on the balloon.The balloon is still well folded and shows no signs of inflation.Other than initially reported, the cover membrane of the pk papyrus is still centered and firmly connected to the stent and shows not damage or irregularity.The blood stain underneath the stent struts of the cover membrane might have falsely led to the assumption that the cover membrane is damaged or missing.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection, every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent as well as the integrity of the cover membrane.Further, the stent outer diameter is verified to 100 %.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be obtained.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 3.0/15
• 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: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 24311976
• Report Number: 8043892-2026-01221
• Device Sequence Number: 5650565
• Product Code: NIV
• UDI-Device Identifier: 07640130447165
• UDI-Public: (01)07640130447165(17)270302(10)02251853
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/18/2026

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: 434888
• Device Lot Number: 02251853
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2026
• 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