MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 3.5/15; CORONARY DRUG-ELUTING STENT

Model Number	453941
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2025
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stent system was selected for treatment of a vain graft.The device could not cross.Guide and stent catheter were withdrawn.The stent shifted into the descending aorta.An attempt was made to remove it with a snare, but this was unsuccessful.The patient is stable.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned device revealed that the balloon is still well folded and shows no signs of inflation.Stent imprints are visible on the balloon surface, indicating that the stent was initially crimped centered in between the two radiopaque markers.The stent was not returned for analysis.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 % and 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 manufacturing or material related root cause could be determined.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a vain graft.The device could not cross.Guide and stent catheter were withdrawn.The stent shifted into the descending aorta.An attempt was made to remove it with a snare, but this was unsuccessful.The patient is stable.

• Brand Name: ORSIRO MISSION US 3.5/15
• 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: 22466344
• Report Number: 8043892-2025-06243
• Device Sequence Number: 20818311
• Product Code: NIQ
• UDI-Device Identifier: 07640130455979
• UDI-Public: (01)07640130455979(17)271201(10)11241590
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/06/2025

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: 453941
• Device Lot Number: 11241590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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
• Patient Sex: Unknown