MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.5/22; CORONARY DRUG-ELUTING STENT

Model Number	453950
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment and was deployed in the patient, although the product had already expired.The hospital found that its protocol was not followed.The device was not confirmed before it was opened on the table, and the hospital system was down for an hour, so there was no warning that the device had expired.No patient complications were reported.The patient will be followed up for 90 days.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes.12-jun-2024 additional information: on (b)(6) 2024 the physician treated a lesion in the mid lad, the 2nd diagonal.The affected product (expiry date 11-apr-2024) was successfully implanted 39 days after the expiry date.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.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted review, no manufacturing related root cause could be identified.The orsiro mission (us) was used after the use by date which is indicated on the product label and warned against in the ifu.It was confirmed that the use by date was not checked prior to the device introduction.From the event description, the procedure was reported to be successful, and the device performed as intended.This indicates that the des was intact at the time of use.Due to the material characteristics and the aging behavior, there is no significant decrease in product performance including drug stability up to 3 years and therefore, no increase in risk is to be expected if the device is used 39 days after its expiration date.Also, the sterility of the orsiro mission would not be compromised if the sterile barrier was maintained until unpackaging as the same packaging and sterilization is used for products with 3 years shelf life.
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.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted review, no manufacturing related root cause could be identified.The orsiro mission (us) was used after the use by date which is indicated on the product label and warned against in the ifu.It was confirmed that the use by date was not checked prior to the device introduction.From the event description, the procedure was reported to be successful, and the device performed as intended.This indicates that the des was intact at the time of use.Due to the material characteristics and the aging behavior, there is no significant decrease in product performance including drug stability up to 3 years and therefore, no increase in risk is to be expected if the device is used 39 days after its expiration date.Also, the sterility of the orsiro mission would not be compromised if the sterile barrier was maintained until unpackaging as the same packaging and sterilization is used for products with 3 years shelf life.

• Brand Name: ORSIRO MISSION (US) 2.5/22
• 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: 19449883
• Report Number: 1028232-2024-02966
• Device Sequence Number: 8567467
• Product Code: NIQ
• UDI-Device Identifier: 07640130456068
• UDI-Public: (01)07640130456068(17)2404
• Combination Product (Y/N): Y
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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: 04/11/2024
• Device Model Number: 453950
• Device Catalogue Number: 453950
• Device Lot Number: 03227408
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 11/12/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/13/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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