MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 2.5/40; CORONARY DRUG-ELUTING STENT

Model Number	453974
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2026
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 of a moderately calcified lesion.Outside patient, the stent slipped off the balloon inside the hemostasis valve.The patient died due to complications related to a complex pci.The patient's death was classified by the hospital as not being caused by the device.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a moderately calcified lesion.Outside patient, the stent slipped off the balloon inside the hemostasis valve.The patient died due to complications related to a complex pci.The patient's death was classified by the hospital as not being caused by the device.
Additional Manufacturer Narrative
Combination product: yes.The affected product was not 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.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent retention force of a defined amount of samples is tested by means of manufacturing process output monitoring.Based on the conducted investigations, no material or manufacturing related root cause could be identified.

• Brand Name: ORSIRO MISSION US 2.5/40
• 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: 24528816
• Report Number: 8043892-2026-02182
• Device Sequence Number: 8504080
• Product Code: NIQ
• UDI-Device Identifier: 07640130456303
• UDI-Public: (01)07640130456303(17)280119(10)1224147801192028
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 453974
• Device Lot Number: 12241478
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown