MAUDE Adverse Event Report: BIOTRONIK AG PK Papyrus 3.5/20; Covered Coronary Stent System

Model Number	434895
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/10/2026
Type of Reportable Event	Death
Event or Problem Description
During balloon dilatation of the prox.Lcx, an ellis type iii coronary peroration occurred.Three pk papyrus coronary covered stents were implanted in an attempt to control the bleeding.Despite the treatment performed, the perforation was reported as not successfully sealed.The patient died during the procedure due to hemorrhage from coronary perforation.The physician stated that this the bleeding might have resulted from concurrent or late micro perforation of the lad, a small ramus branch, or the lm.The cause of the reported event is currently under investigation.This report pertains to one of three pk papyrus devices used in the same procedure involving the same patient and clinical event.The other two devices are reported separately under mdr report 8043892-2006-073004 and 8043892-2006 073005.

• Brand Name: PK Papyrus 3.5/20
• 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: 50400884
• Report Number: 8043892-2026-07303
• Device Sequence Number: 21488153
• Product Code: NIV
• UDI-Device Identifier: 07640130447233
• UDI-Public: (01)07640130447233(17)271104(10)10253935
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 08/24/2026

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: 434895
• Device Lot Number: 10253935
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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