MAUDE Adverse Event Report: BIOTRONIK AG Orsiro Mission US 2.75/40; coronary drug-eluting stent

Model Number	453975
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/10/2026
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 (65% stenosis degree) in a mildly tortuous segment of the proximal rca.During the advancement to the target lesion, resistance was met, resulting in bending and deformation of the stent struts.The device was not deployed.Subsequently, the patient moved their arm, which led to dislodgement of the guiding catheter, guidewire, and stent into the aorta.An attempt was made to retrieve all devices through the radial sheath; however, the stent together with the distal tip could not be withdrawn.A radial artery cutdown procedure was subsequently required to remove the remaining part.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (65% stenosis degree) in a mildly tortuous segment of the proximal rca.During the advancement to the target lesion, resistance was met, resulting in bending and deformation of the stent struts.The device was not deployed.Subsequently, the patient moved their arm, which led to dislodgement of the guiding catheter, guidewire, and stent into the aorta.An attempt was made to retrieve all devices through the radial sheath; however, the stent together with the distal tip could not be withdrawn.A radial artery cutdown procedure was subsequently required to remove the remaining part.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes.Additional information: the complaint device was unable to cross the lesion and had to be withdrawn.During the movement of the arm, the stent and the device became bent and could not be pulled back into the introducer.The distal part of the complaint device fractured off from the remaining device and were left behind in the radial artery.The complaint device was discarded at the hospital.The complaint device was not returned for analysis.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.In addition, the provided image from the angiogram was reviewed.The review of the image from the angiogram showed the fractured distal segment of the delivery system with one xray marker and the deformed stent in the radial artery.The complaint device and thus the actual complaint event is not visible.The provided image does therefore not provide further relevant information regarding the root cause of the complaint.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 outer diameter of a defined amount of samples is verified.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause for the complaint event (i.E., the stent deformation) was determined.The fracture of the complaint device was caused by a consequence of unfavorable circumstances during the intervention (i.E., the sudden moving of the arm by the patient).

• Brand Name: Orsiro Mission US 2.75/40
• 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: jana burger ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 50494942
• Report Number: 8043892-2026-08112
• Device Sequence Number: 10592777
• Product Code: NIQ
• UDI-Device Identifier: 07640130456310
• UDI-Public: (01)07640130456310(17)280929(10)09251674
• 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
• 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): 09/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453975
• Device Lot Number: 09251674
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown