MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 2.5/22; DRUG-ELUTING STENT SYSTEM, CORONARY

Model Number	453950
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When pulling the orsiro mission out of the hoop and preparing to load over the guidewire it was noticed, that the distal part of the stent was flared up off the balloon.The device was never inserted inside the patient.
Additional Manufacturer Narrative
Combination product: yes.

• Brand Name: ORSIRO MISSION US 2.5/22
• Common Device Name: DRUG-ELUTING STENT SYSTEM, CORONARY
• 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: 24843488
• Report Number: 8043892-2026-03182
• Device Sequence Number: 5623864
• Product Code: NIQ
• UDI-Device Identifier: 07640130456068
• UDI-Public: (01)07640130456068(17)281007(10)09251975
• Combination Product (Y/N): N
• 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): 06/02/2026

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
• Device Model Number: 453950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown