MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US 4.5/20; COVERED CORONARY STENT SYSTEM

Model Number	434897
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Pk papyrus covered stent systems were selected for treatment of a pseudoaneurysm of the hepatic artery.Patient underwent a whipple procedure with a hepatic artery bypass.A pseudoaneurysm developed at proximal anastomosis.After implanting a 4.0/26, a 4.5/26 and a 4.0/20 pk papyrus stent, repeat angiogram demonstrated some separation between the 2 distal stents.At this point an attempt was made to insert a fourth papyrus stent (complaint device) but this was unsuccessful.It was decided to switch to a stiffer wire, however the stent came off the balloon and got caught at the level of the celiac artery.To ensure that this would not migrate over an 014 wire we placed a 6/15 mm bare-metal stent in the celiac artery to trap the dislodged stent.No adverse consequences and the patient did well.

• Brand Name: PK PAPYRUS US 4.5/20
• 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: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 24893425
• Report Number: 8043892-2026-03233
• Device Sequence Number: 15728381
• Product Code: NIV
• UDI-Device Identifier: 07640130447257
• UDI-Public: (01)07640130447257(17)261211(10)11243656
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/09/2026

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: 434897
• Device Lot Number: 11243656
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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