MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 4.0/13; CORONARY DRUG-ELUTING STENT

Model Number	453936
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
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 technical investigation revealed that the hypotube has fractured at the distal end of the kink protector.The cross-section of the hypotube at the fracture sites is no longer circular but compressed into an ellipse.The polymer coating is plastically deformed.The hypotube is also strongly kinked about 171 mm distal to the fracture site.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of the patients body.In addition, the stent was found mildly deformed in its center (i.E.Few struts are slightly bent outwards).The crimped diameter of the stent does not comply anymore with the specification.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the preparations for the intervention.
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment.When connecting inflation device to end of stent catheter (hub) it sheared off from the shaft.This occurred outside of the patient and was never used.After additional correspondence with the local staff, it was clarified that the actual complaint event is that the hypotube fractured while connecting the inflation device.

• Brand Name: ORSIRO MISSION (US) 4.0/13
• 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: 18057843
• Report Number: 1028232-2023-05615
• Device Sequence Number: 6849089
• Product Code: NIQ
• UDI-Device Identifier: 07640130455924
• UDI-Public: (01)07640130455924(17)2505
• 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
• Report Date (Section B): 11/02/2023

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: 05/23/2025
• Device Model Number: 453936
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04233871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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 Sex: Unknown