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

Model Number	453947
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment of a severely calcified lesion in the moderately tortuous mid lad.It was not possible to cross the lesion with the orsiro mission.When removing it from the vessel the stent became stuck on a transcatheter aortic valve replacement (tavr).As it was tried to free the stent from the tavr, it came off the balloon.It was possible to snare and remove the orsiro mission from the patient.The intervention was completed with another stent.
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 technical investigation revealed that the balloon is well folded and shows no signs of inflation.Stent imprints on the exposed balloon surface indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was returned separately entangled with a snare.The stent is severely deformed over its entire length.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 and the stent retention force of a defined amount of samples is tested from every lot.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.Considering the physicians event description, the most probable root cause for the complaint event is related to the patients anatomy (i.E.Transcatheter aortic valve replacement).

• 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: 15848640
• Report Number: 1028232-2022-05956
• Device Sequence Number: 5027323
• Product Code: NIQ
• UDI-Device Identifier: 07640130456037
• UDI-Public: (01)07640130456037(17)2404
• 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): 11/07/2022

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: 04/07/2024
• Device Model Number: 453947
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03227407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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: Female