MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION US 3.0/30; CORONARY DRUG-ELUTING STENT

Model Number	453964
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 the mid to distal lad.During the removal of the stent cover of the orsiro mission there was resistance.The stent was discovered to be damaged, and the balloon appeared to be inflated on the end of the stent.Another orsiro mission was used without any issues.The patient had no complications during or post procedure and was discharged home from the hospital the next day.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of the mid to distal lad.During the removal of the stent cover of the orsiro mission there was resistance.The stent was discovered to be damaged, and the balloon appeared to be inflated on the end of the stent.Another orsiro mission was used without any issues.The patient had no complications during or post procedure and was discharged home from the hospital the next day.
Additional Manufacturer Narrative
Combination product: yes.The affected device was not 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.In addition, a photograph provided was reviewed.The photograph shows the affected device with a partially inflated balloon.The balloon and the stent are open at both ends.The stent protector is located distal to the stent and balloon.The outer diameter of the dilated stent portions is larger than the outer diameter of the protector cap.It can therefore be excluded beyond reasonable doubt that the damage was already present on delivery of the device.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and 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 outer diameter is verified to 100 %.Based on the conducted investigations, no material or manufacturing related root cause could be determined.The most probable root cause for the reported event is related to the handling during the preparations for the intervention, i.E.Application of pressure.

• Brand Name: ORSIRO MISSION US 3.0/30
• 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: 23653769
• Report Number: 8043892-2025-11119
• Device Sequence Number: 17335864
• Product Code: NIQ
• UDI-Device Identifier: 07640130456204
• UDI-Public: (01)07640130456204(17)260911(10)08243183
• 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
• 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): 01/28/2026

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: 09/11/2026
• Device Model Number: 453964
• Device Lot Number: 08243183
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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