MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.75/18; CORONARY DRUG-ELUTING STENT

Model Number	453945
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment of a distal lad lesion.The stent was delivered but needed to change position, since it moved.After repositioning it was noticed that the stent was dislodged.The stent delivery was pulled back, and it was confirmed that the stent had dislodged.Another stent was deployed to crush the dislodged stent against the vessel wall.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned product revealed that the balloon is still well folded and shows no signs of inflation.Stent imprints are clearly visible on the balloon surface, indicating that the stent was initially crimped centered in between the two radiopaque markers.The stent was not returned for analysis as reported.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, no manufacturing or material related root cause could be determined.
Additional Manufacturer Narrative
Combination product: yes.Corrected the initial reporter information.Reference capa# nc-24-004.The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned product revealed that the balloon is still well folded and shows no signs of inflation.Stent imprints are clearly visible on the balloon surface, indicating that the stent was initially crimped centered in between the two radiopaque markers.The stent was not returned for analysis as reported.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, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO MISSION (US) 2.75/18
• 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: 18712744
• Report Number: 1028232-2024-00868
• Device Sequence Number: 8165508
• Product Code: NIQ
• UDI-Device Identifier: 07640130456013
• UDI-Public: (01)07640130456013(17)2404
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 10/17/2024

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: 04/13/2024
• Device Model Number: 453945
• Device Catalogue Number: 453945
• Device Lot Number: 03227674
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/22/2024; 10/17/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/25/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• 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