MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.5/35; CORONARY DRUG-ELUTING STENT

Model Number	453971
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of the popliteal artery.The device failed to inflate when trying to place the stent.
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
The orsiro mission drug-eluting stent system was selected for treatment of the popliteal artery.The device failed to inflate when trying to place the stent.
Additional Manufacturer Narrative
Combination product: yes.Neither the affected device nor the angiographic material was 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 passed all in-process and final inspections.In addition to visual inspections each device is tested for air tightness by means of a helium leak test.All tested products of the lot successfully passed this test.We can therefore confirm that the device was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.It should be noted that the orsiro mission stent system is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-st elevation myocardial infarction or documented silent ischemia.

• Brand Name: ORSIRO MISSION (US) 3.5/35
• 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: 20979856
• Report Number: 1028232-2024-06556
• Device Sequence Number: 18237425
• Product Code: NIQ
• UDI-Device Identifier: 07640130456273
• UDI-Public: (01)07640130456273(17)2512
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2025
• Device Model Number: 453971
• Device Catalogue Number: 453971
• Device Lot Number: 11233026
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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: Unknown