MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 2.5/30; DRUG-ELUTING STENT SYSTEM, CORONARY

Model Number	453962
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro mission us stent system was delivered to the target lesion within the lad but after inflation the vessel appeared the same and it was noticed thate there was no stent loaded on the balloon.Another stent was then successfully deployed.

• Brand Name: ORSIRO MISSION US 2.5/30
• 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: 24842542
• Report Number: 8043892-2026-03161
• Device Sequence Number: 20239921
• Product Code: NIQ
• UDI-Device Identifier: 07640130456181
• UDI-Public: (01)07640130456181(17)281001(10)09250154
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 453962
• Device Lot Number: 09250154
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• 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