MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US 3.5/15; COVERED CORONARY STENT SYSTEM

Model Number	434889
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiogenic Shock (2262)
Date of Event	02/26/2026
Type of Reportable Event	Death
Event or Problem Description
The pk papyrus covered stent system was selected for treatment of a perforation in the lad.While delivering the stent, it became dislodged from balloon catheter and embolized in the coronary artery.On the same day, the patient passed away due to cardiogenic shock and arrest.
Additional Manufacturer Narrative
The affected pk papyrus stent system was returned and subjected to a detailed technical investigation.Images of the case such as angiographies and additional clinical information could not be obtained.The 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 balloon is well folded and shows no signs of inflation.Stent imprints on the exposed balloon surface indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was not returned.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 investigation, 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
The pk papyrus covered stent system was selected for treatment of a perforation in the lad.While delivering the stent, it became dislodged from balloon catheter and embolized in the coronary artery.On the same day, the patient passed away due to cardiogenic shock and arrest.

• Brand Name: PK PAPYRUS US 3.5/15
• 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: 24589698
• Report Number: 8043892-2026-02272
• Device Sequence Number: 12184706
• Product Code: NIV
• UDI-Device Identifier: 07640130447172
• UDI-Public: (01)07640130447172(17)270520(10)04253360
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 434889
• Device Lot Number: 04253360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown