MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.5/18; CORONARY DRUG-ELUTING STENT

Model Number	453947
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, this device was intended to treat a lesion (100 percent stenosis degree) in the mid lad / om.The lesion was pre-dilated.Thereafter, the affected orsiro mission (expiry date 26.Apr.2025) was introduced into the patients body and successfully implanted without incidence, however, 32 days after the expiry date.
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.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.Based on the conducted review, no manufacturing related root cause could be identified.The orsiro mission was used after the ¿use by¿ date which is indicated on the product label and warned against in the ifu.It was confirmed that the ¿use by¿ date was overlooked and not verified.

• Brand Name: ORSIRO MISSION (US) 3.5/18
• 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: 22292233
• Report Number: 1028232-2025-02954
• Device Sequence Number: 8310282
• Product Code: NIQ
• UDI-Device Identifier: 07640130456037
• UDI-Public: (01)07640130456037(17)2504
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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 Expiration Date: 04/26/2025
• Device Model Number: 453947
• Device Catalogue Number: 453947
• Device Lot Number: 03236389
• 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: 05/30/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2023
• 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