MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.0/13; CORONARY DRUG-ELUTING STENT

Model Number	453934
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
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 stent is severely deformed at its distal end, i.E.Several struts are strongly bent.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the bent struts were initially crimped on the balloon.In addition, the hypotube has fractured about 206 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 further strongly kinked in close vicinity to fracture sites.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of the patients body.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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.It should be noted that the ifu advises the user to exercise care during handling to reduce the possibility of accidental breakage, bending, and kinking of the stent system shaft.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of a severely calcified lesion in a severely tortuous part of the ostial lcx.After predilation of the lesion, the affected orsiro mission was introduced into the patients body during which the catheter shaft was damaged.

• Brand Name: ORSIRO MISSION (US) 3.0/13
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 22132996
• Report Number: 1028232-2025-02701
• Device Sequence Number: 12623840
• Product Code: NIQ
• UDI-Device Identifier: 07640130455900
• UDI-Public: (01)07640130455900(17)2801
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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
• Device Model Number: 453934
• Device Catalogue Number: 453934
• Device Lot Number: 12242436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Patient Sex: Male