MAUDE Adverse Event Report: BIOTRONIK AG Orsiro Mission US 2.25/26; coronary drug-eluting stent

Model Number	453955
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion in a moderate tortuous segment of the om.After pre-dilatation, the device was introduced into the patient's body but could not pass the lesion.A shorter stent was used successfully to finish the procedure.
Additional Manufacturer Narrative
Combination product: yes.

• Brand Name: Orsiro Mission US 2.25/26
• Common Device Name: coronary drug-eluting stent
• 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: jana burger ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 50782790
• Report Number: 8043892-2026-09021
• Device Sequence Number: 18534461
• Product Code: NIQ
• UDI-Device Identifier: 07640130456112
• UDI-Public: (01)07640130456112(17)281202(10)10256754
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453955
• Device Lot Number: 10256754
• 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: 09/02/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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
• Patient Sex: Unknown