MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 4.0/9; CORONARY DRUG-ELUTING STENT

Model Number	453930
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	02/14/2024
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.The treated lesion was a 100 percent occluded large om.A wire and microcatheter were used to cross the lesion.Pre-dilatation was done and a 3.0/40 orsiro was placed and post dilated.Significant calcification was noted on ivus proximal to the stent and a orsiro mission 4.0/9 was selected to place proximal to the previous implanted stent.While positioning, the orsiro mission 4.0/9 stent came off the delivery balloon and migrated distally to the distal vessel but was still on the wire.A balloon was placed inside the dislodged stent and inflated to adhere the stent to the wall of the distal om.A guide extension was then used and a orsiro 4.0/13 was placed proximal inside the orsiro 3.0/40.The patient had continuous chest pain throughout the procedure.A second cath was done on (b)(6) 2024.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, five photographs and a video taken from the angiogram were reviewed.The technical investigation confirmed that the stent has dislodged from the balloon.The balloon is well folded and shows no signs of inflation.Stent imprints were observed on the exposed balloon surface, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was implanted and thus not returned for analysis.The photographs show the occluded target lesion prior to, during and after its treatment.The affected device is shown during positioning but the actual complaint event is not visible.The video provided shows the dislodged stent in the distal om.The photographs and the video do not contain further relevant information regarding the root cause of the complaint.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 of the device being subject to this complaint, no material or manufacturing 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 detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, five photographs and a video taken from the angiogram were reviewed.The technical investigation confirmed that the stent has dislodged from the balloon.The balloon is well folded and shows no signs of inflation.Stent imprints were observed on the exposed balloon surface, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was implanted and thus not returned for analysis.The photographs show the occluded target lesion prior to, during and after its treatment.The affected device is shown during positioning but the actual complaint event is not visible.The video provided shows the dislodged stent in the distal om.The photographs and the video do not contain further relevant information regarding the root cause of the complaint.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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO MISSION (US) 4.0/9
• 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: 18778803
• Report Number: 1028232-2024-01017
• Device Sequence Number: 4324716
• Product Code: NIQ
• UDI-Device Identifier: 07640130455863
• UDI-Public: (01)07640130455863(17)2509
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2024

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: 09/02/2025
• Device Model Number: 453930
• Device Catalogue Number: 453930
• Device Lot Number: 08230883
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 10/21/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/09/2024; 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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 Age: 57 YR
• Patient Sex: Male