MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.5/30; CORONARY DRUG-ELUTING STENT

Model Number	453962
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
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 lesion in the rca.The device was advanced to the mid part of the rca and inflated to nominal pressure.In the post-angio the lesion looked to be the same and the stent was not seen.Fluro was then used to trace the catheter, but the stent was not visible.The back of the table was checked, and it was noticed that the stent was still on the stylet.
Additional Manufacturer Narrative
Combination product: yes.Only the stent was returned and subjected to a detailed technical analysis.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The stent was returned on the transportation wire about 157 mm proximal to the protector cap.The stent is severely deformed over its entire length, i.E.It is flat, and several struts are severely bent.The stent protector is bent in its distal portion.The delivery system was not returned for analysis.Review of the production documentation confirmed that the device 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 of the device being subject to this complaint, no manufacturing or material related root cause could be determined.It should be noted that the ifu advises the user to visually inspect the stent system prior to the procedure and not to use if any defects are noted.

• Brand Name: ORSIRO MISSION (US) 2.5/30
• 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: 18004103
• Report Number: 1028232-2023-05419
• Device Sequence Number: 6650862
• Product Code: NIQ
• UDI-Device Identifier: 07640130456181
• UDI-Public: (01)07640130456181(17)2402
• 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): 01/08/2024

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: 02/09/2024
• Device Model Number: 453962
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01224831
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: Unknown