MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.25/9; CORONARY DRUG-ELUTING STENT

Model Number	453925
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro mission drug-eluting stent embolized in a severely calcified and tortuous distal lcx.The patient was flailing throughout the case, which complicated matters as well.It is believed that the doctor was able to balloon embolize the stent into the vessel wall, but it could not be confirmed based on limited stent visibility.Stent catheter was disposed in the heat of a difficult case, so it is not available for inspection.After additional correspondence with the local staff, it was clarified that there were three 90 percent lesions which had already been ballooned and stented, except for the distal segment.When trying to deliver the smallest/shortest stent to the distal location, the system was stuck inside the proximal stents and then dislodged during the retrieval.
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.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent retention force of a defined amount of samples is tested by means of manufacturing process output monitoring.Based on the conducted investigations, no material or manufacturing related root cause could be determined.Considering the event description, the most probable root cause for the reported event is related to the patients anatomy (i.E.Previously implanted stents).Please note that the orsiro mission ifu advises the user, when treating multiple lesions, to initially stent the distal lesion followed by stenting of the proximal lesion.
Additional Manufacturer Narrative
Combination product: yes, corrected the initial reporter information.Reference capa# nc-24-004.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.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent retention force of a defined amount of samples is tested by means of manufacturing process output monitoring.Based on the conducted investigations, no material or manufacturing related root cause could be determined.Considering the event description, the most probable root cause for the reported event is related to the patients anatomy (i.E.Previously implanted stents).Please note that the orsiro mission ifu advises the user, when treating multiple lesions, to initially stent the distal lesion followed by stenting of the proximal lesion.

• Brand Name: ORSIRO MISSION (US) 2.25/9
• 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: 19817697
• Report Number: 1028232-2024-03897
• Device Sequence Number: 12957018
• Product Code: NIQ
• UDI-Device Identifier: 07640130455818
• UDI-Public: (01)07640130455818(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
• 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: 03/19/2026
• Device Model Number: 453925
• Device Catalogue Number: 453925
• Device Lot Number: 02243807
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2024
• 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