MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 2.25/22; CORONARY DRUG-ELUTING STENT

Model Number	453949
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (70 % stenosis degree) in a mildly tortuous segment of the proximal d1.An unknown stent was implanted previously in the lad, but unclear if it was in the same intervention.After the lad stent was fenestrated and the target lesion was pre-dilated, the complaint device was introduced into the patient but failed to fully cross the target lesion.During the attempt to remove the complaint device, the stent dislodged into the proximal lad.A snaring attempt had to be interrupted as the patient developed a stemi and the physician decided to crush the dislodged stent to the vessel wall in the proximal lad.Afterwards, another stent system was successfully implanted over the length of the crushed stent.Another manufacturers stent was implanted into the proximal d1 segment instead.The complaint device was discarded at the hospital.
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.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 determined.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).Please note that the orsiro mission ifu advises the user, when treating multiple lesions, to initially stent the distal lesion followed by stenting of the proximal lesion.

• Brand Name: ORSIRO MISSION US 2.25/22
• 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: tina mueller ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22574256
• Report Number: 8043892-2025-07081
• Device Sequence Number: 13155878
• Product Code: NIQ
• UDI-Device Identifier: 07640130456051
• UDI-Public: (01)07640130456051(17)260605(10)05240051
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 07/23/2025

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 Expiration Date: 06/05/2026
• Device Model Number: 453949
• Device Lot Number: 05240051
• 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
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown