MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 3.0/9; CORONARY DRUG-ELUTING STENT

Model Number	453928
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
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 mildly calcified lesion with (80% stenosis degree) in a mildly tortuous segment of the proximal lad.After the device had been advanced to the pre-dilated target lesion, the balloon was inflated to 10 atm in vitro, but the stent did not deploy.Instead, it "dog boned".The stent was removed from the patient and inflated to 18 atm on the bench.The stent remains embedded on the balloon.
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 has partially been inflated.A large amount of dried contrast medium residue was observed in the balloon- and inflation lumen.Judging from the x-ray markers, the stent is displaced on the balloon by about 9 mm in distal direction.The stent is deformed at both ends, i.E.Several struts are bent.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped in between the two radiopaque markers.However, considering the event description the displacement and deformation of the stent most likely occurred after the reported event.During inflation with 10 atm (np), the balloon opened and held the pressure.No damage or irregularity of the ballon (such as e.G.Dog bone) could be identified.Review of the production documentation verified that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections, each device is tested for air tightness by means of a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion with (80% stenosis degree) in a mildly tortuous segment of the proximal lad.After the device had been advanced to the pre-dilated target lesion, the balloon was inflated to 10 atm in vitro, but the stent did not deploy.Instead, it "dog boned".The stent was removed from the patient and inflated to 18 atm on the bench.The stent remains embedded on the balloon.

• Brand Name: ORSIRO MISSION US 3.0/9
• 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: 24631161
• Report Number: 8043892-2026-03034
• Device Sequence Number: 8985924
• Product Code: NIQ
• UDI-Device Identifier: 07640130455849
• UDI-Public: (01)07640130455849(17)260410(10)03240054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/05/2026

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 Expiration Date: 04/10/2026
• Device Model Number: 453928
• Device Lot Number: 03240054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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