MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.0/22; CORONARY DRUG-ELUTING STENT

Model Number	453952
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes neither the affected products 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 devices were manufactured according to specifications and passed all inprocess and final inspections.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the tip is visually inspected for damages to 100 percent.Based on the conducted investigations, no material or manufacturing related root cause could be determined.
Event or Problem Description
The 1st orsiro mission would not cross lesion.When removing the device from patients body, it was detected that the distal tip was damaged (reported separately).Subsequently, the complaint orsiro mission with same size was insert but did not cross again.The distal tip was damaged as well.Finally, an orsiro mission 3.0/26 was inserted, and the procedure was completed.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes, corrected the initial reporter information.Reference capa# nc-24-004.Neither the affected products 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 devices were manufactured according to specifications and passed all inprocess and final inspections.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the tip is visually inspected for damages to 100 percent.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO MISSION (US) 3.0/22
• 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: 19709551
• Report Number: 1028232-2024-03658
• Device Sequence Number: 3116140
• Product Code: NIQ
• UDI-Device Identifier: 07640130456082
• UDI-Public: (01)07640130456082(17)2603
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2024

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: 03/14/2026
• Device Model Number: 453952
• Device Catalogue Number: 453952
• Device Lot Number: 02243811
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 11/20/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/24/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male