MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.5/40; CORONARY DRUG-ELUTING STENT

Model Number	453974
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment of a moderately calcified lesion (90 percent stenosis degree) in the moderately tortuous cx.The device could not cross the lesion and was attempted to be withdrawn, but the stent was bunched up and could not be pulled back through the guide catheter.Everything had to be removed and a snare was used to pull the entire stent balloon out.
Additional Manufacturer Narrative
Combination product: yes.
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 affected instrument was returned together with the 6f guiding catheter, 6f introducer sheath, 0.014 inch guidewire and the snare used in the intervention.In as-returned state the balloon and the stent were located at the distal end of the guiding catheter.The stent is severely elongated, and several struts are bent.Judging from the x-ray markers the stent is displaced on the balloon by about 6 mm in distal direction.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped centered on the balloon.Moreover, the hypotube has fractured.The device hub and a part of the hypotube were not returned.The returned guiding catheter and introducer sheath show severe deformations at their distal ends.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.Based on the conducted investigations, no manufacturing or material related root cause was determined.

• Brand Name: ORSIRO MISSION (US) 2.5/40
• 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: 13870639
• Report Number: 1028232-2022-01469
• Device Sequence Number: 20012786
• Product Code: NIQ
• UDI-Device Identifier: 07640130456303
• UDI-Public: 07640130456303
• 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): 03/08/2022

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: 10/25/2023
• Device Model Number: 453974
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09216006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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: Male