MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.5/26; CORONARY DRUG-ELUTING STENT

Model Number	453959
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes the complaint instrument was not returned.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the instrument 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.
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment, but the stent dislodged from the balloon when the packaging stylet was removed from the complaint instrument.This occurred outside of the patient during the preparations for the intervention.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The delivery system and the stent were returned separately with the stent on the transportation wire inside the protector cap.The stent appears pinched at its distal end.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped centered in between the two radiopaque markers.The balloon is well folded and shows no signs of inflation.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent and the stent retention force of a defined amount of samples is tested from every lot.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the preparations for the intervention.It should be noted that the ifu advises the user to pull at the very distal end of the stent protector to avoid dislocation of the stent.

• Brand Name: ORSIRO MISSION (US) 3.5/26
• 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: 17698983
• Report Number: 1028232-2023-04408
• Device Sequence Number: 6691076
• Product Code: NIQ
• UDI-Device Identifier: 07640130456150
• UDI-Public: (01)07640130456150(17)250
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: 02/14/2025
• Device Model Number: 453959
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01233013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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
• Patient Sex: Female