MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 4.0/15; CORONARY DRUG-ELUTING STENT

Model Number	453942
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment.The device failed to cross.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment.The device failed to cross.
Additional Manufacturer Narrative
Combination product: yes.Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO MISSION US 4.0/15
• 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: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 23713032
• Report Number: 8043892-2025-11253
• Device Sequence Number: 8910803
• Product Code: NIQ
• UDI-Device Identifier: 07640130455986
• UDI-Public: (01)07640130455986(17)260411(10)03240056
• 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
• 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): 01/06/2026

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 Expiration Date: 04/11/2026
• Device Model Number: 453942
• Device Lot Number: 03240056
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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