MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.0/40; CORONARY DRUG-ELUTING STENT

Model Number	453976
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Asystole (4442)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
Stent sheared off the balloon and had to be snared from left main.After the device was removed, an extension catheter was inserted and it was planned to implant another orsiro mission, but patient then went asystole and hypotensive.Cpr/acls was initiated, and the patient was intubated.An impella was then placed as well.Patient was given a second orsiro mission stent which was deployed successfully, and the patient went home in good health.
Additional Manufacturer Narrative
Combination product: yes.19-jun-2024 additional information: treated was a moderately-severely calcified lesion (90 percent stenosis degree) in a mildly tortuous part of the proximal lad.The cathlab report notes that there were previously implanted stents from the proximal lad to the mid lad with severe diffuse in-stent restenosis with multiple areas of 90 percent stenosis.A laser atherectomy of the proximal to mid lad in-stent restenosis was performed, and the proximal and mid lad stents were pre-dilated with a 2.5 x 20 mm balloon.An orsiro mission 2.5/40 was successfully implanted in the mid lad.Thereafter, the affected device was introduced into the patients body.The affected product was not returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the cathlab report provided was reviewed.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, no manufacturing related root cause could be identified.
Additional Manufacturer Narrative
Combination product: yes, corrected the initial reporter information.Reference capa# nc-24-004.The affected product was not returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the cathlab report provided was reviewed.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, no manufacturing related root cause could be identified.

• Brand Name: ORSIRO MISSION (US) 3.0/40
• 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: 19460959
• Report Number: 1028232-2024-03008
• Device Sequence Number: 12425368
• Product Code: NIQ
• UDI-Device Identifier: 07640130456327
• UDI-Public: (01)07640130456327(17)2511
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2025
• Device Model Number: 453976
• Device Catalogue Number: 453976
• Device Lot Number: 10234355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 11/05/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/19/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male