MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 2.25/26; CORONARY DRUG-ELUTING STENT

Model Number	453955
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a detailed 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 revealed that the balloon is still well folded and has not been inflated.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped centered on the balloon.The stent was not returned.Review of the production documentation verified that the device was manufactured according to specifications and passed all in-process controls and the final inspection.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 of the device being subject to this complaint, no manufacturing or material related root cause could be determined.It should be noted that, according to the ifu, the distal lesion should be initially stented, followed by stenting of the proximal lesion when treating multiple lesions.The ifu further advises the user to pre-dilate the lesion using a recommended balloon diameter that is 0.5 mm smaller than the reference vessel diameter and balloon length equal to or shorter than the target lesion length.
Event or Problem Description
Orsiro mission was selected for treatment of a moderately calcified lesion (100% stenosis degree) in a moderately tortuous part of a totally occupied rca by direct stenting.Three orsiro missions stents were successfully implanted from the ostium to the distal rca.Thereafter, the affected orsiro mission was introduced but "was held up going through the proximal stent".During device withdrawal, the stent dislodged from the balloon, leaving the stent half in proximal rca and in the guiding catheter.The stent was successfully retrieved with a snare.In an additional intervention two days later, a stent could be successfully implanted in the distal rca.The patient did fine and was discharged home.

• Brand Name: ORSIRO MISSION US 2.25/26
• 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: 25159498
• Report Number: 8043892-2026-04231
• Device Sequence Number: 9516473
• Product Code: NIQ
• UDI-Device Identifier: 07640130456112
• UDI-Public: (01)07640130456112(17)290316(10)02264068
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 05/13/2026

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: 453955
• Device Lot Number: 02264068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2026
• 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