MAUDE Adverse Event Report: BIOTRONIK AG PK Papyrus US 3.0/20; Covered Coronary Stent System

Model Number	434894
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/09/2026
Type of Reportable Event	Death
Event or Problem Description
The patient had severe underlying cardiovascular disease, including multivessel coronary artery disease and reduced left ventricular function.During pci of the mid to distal lad, a type iii coronary perforation was reported after des placement.The perforation was treated with two pk papyrus covered stents and was reported to have been successfully sealed.During the same procedure, acute thrombosis/occlusion of both pk papyrus stents was reported, resulting in no-reflow and ventricular tachycardia/cardiac arrest.Following further intervention, final angiography reportedly showed timi 3 flow.The patient subsequently developed refractory shock and died later the same day.The cause of the acute stent thrombosis/occlusion and its potential contribution to the patient's death are under investigation.This report pertains to one of two pk papyrus devices used during the same procedure involving the same patient and clinical event.Since it could not be determined if only one or both pkps occluded, the second device is reported separately under manufacturer report number 8043892-2026-08115.
Event or Problem Description
The patient had severe underlying cardiovascular disease, including multivessel coronary artery disease and reduced left ventricular function.During pci of the mid to distal lad, a type iii coronary perforation was reported after des placement.The perforation was treated with two pk papyrus covered stents and was reported to have been successfully sealed.During the same procedure, acute thrombosis/occlusion of both pk papyrus stents was reported, resulting in no-reflow and ventricular tachycardia/cardiac arrest.Following further intervention, final angiography reportedly showed timi 3 flow.The patient subsequently developed refractory shock and died later the same day.The cause of the acute stent thrombosis/occlusion and its potential contribution to the patient's death are under investigation.This report pertains to one of two pk papyrus devices used during the same procedure involving the same patient and clinical event.Since it could not be determined if only one or both pkps occluded, the second device is reported separately under manufacturer report number 8043892-2026-08115.
Additional Manufacturer Narrative
New information: it was intended to treat a lesion with 99% stenosis degree in the medial to distal lad.The affected pk papyrus stent system was not returned to the manufacturer 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, discharge letter) and the production documentation was reviewed to establish whether a device deficiency contributed to this event.Review of the production documentation confirmed that the devices were manufactured according to specifications and fulfilled all the requirements of inprocess and final inspection.Based on the provided documentation and the conducted review no manufacturing related root cause could be identified.The treating physician rated the occurrence as a 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.

• Brand Name: PK Papyrus US 3.0/20
• 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: 50492892
• Report Number: 8043892-2026-08114
• Device Sequence Number: 21494438
• Product Code: NIV
• UDI-Device Identifier: 07640130447226
• UDI-Public: (01)07640130447226(17)261028(10)10241213
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: H17004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 10/01/2026

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: 434894
• Device Lot Number: 10241213
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown