MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO MISSION; CORONARY DRUG-ELUTING STENT

Model Number	453976
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a lesion with 70% stenosis degree in the at.During procedure the hypotube broke in the sheath.
Additional Manufacturer Narrative
Combination product: yes.
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 hypotube has fractured about 705 mm distal to the kink protector.The cross-section of the hypotube at the fracture sites is no longer circular but compressed into an ellipse.The polymer coating is plastically deformed.The hypotube is kinked close to the fracture sites.The findings indicate that the hypotube most probably fractured as a result of significant bending outside the patient's body.The stent itself shows no damage or irregularity.The crimped diameter of the stent complies with the specification.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The most probable root cause for the reported event is related to the handling during the procedure.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a lesion with 70% stenosis degree in the at.During procedure the hypotube broke in the sheath.

• Brand Name: ORSIRO MISSION
• 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: 23540644
• Report Number: 8043892-2025-10311
• Device Sequence Number: 9775415
• Product Code: NIQ
• UDI-Device Identifier: 07640130456327
• UDI-Public: (01)07640130456327(17)260710(10)06243462
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/30/2026

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: 07/10/2026
• Device Model Number: 453976
• Device Lot Number: 06243462
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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