MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 2.25/13; CORONARY DRUG-ELUTING STENT

Model Number	453931
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro mission was used to treat a moderately calcified lesion (90% stenosis degree) in a severely tortuous segment of the distal lcx.At the distal tip of a stent implanted more than a year earlier, the orsiro mission likely caught on the proximal edges and detached from the balloon.Since it was still attached to the guidewire, the stent was pulled into the distal left main trunk, where it was dilated to 4.0 mm, creating a temporary stent from the distal left main trunk to the proximal lcx.Treatment of the distal lcx was then abandoned.
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
The orsiro mission was used to treat a moderately calcified lesion (90% stenosis degree) in a severely tortuous segment of the distal lcx.At the distal tip of a stent implanted more than a year earlier, the orsiro mission likely caught on the proximal edges and detached from the balloon.Since it was still attached to the guidewire, the stent was pulled into the distal left main trunk, where it was dilated to 4.0 mm, creating a temporary stent from the distal left main trunk to the proximal lcx.Treatment of the distal lcx was then abandoned.
Additional Manufacturer Narrative
Combination product: yes.Neither the affected device not 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.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.Considering the event description, the most probable root cause for the reported event is related to the patient's anatomy (i.E.Previously implanted stent).Besides, it should be noted that the ifu advises the user not to post-dilate the stent to more than the maximum expandable diameter.

• Brand Name: ORSIRO MISSION US 2.25/13
• 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: 24589699
• Report Number: 8043892-2026-02271
• Device Sequence Number: 5688898
• Product Code: NIQ
• UDI-Device Identifier: 07640130455870
• UDI-Public: (01)07640130455870(17)280405(10)03251785
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/23/2026

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: 453931
• Device Lot Number: 03251785
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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