MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/26; CORONARY DRUG-ELUTING STENT

Model Number	364505
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.Upon unpacking and removing the protector cap, the stent dislodged from the balloon.
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 balloon is well folded and shows no signs of inflation.Microscopic inspection of the exposed balloon surface revealed stent imprints, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was returned on the transportation wire inside the protector cap.The stent is not deformed or damaged.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent and 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 was determined.

• Brand Name: ORSIRO 2.25/26
• 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: 15103762
• Report Number: 1028232-2022-03779
• Device Sequence Number: 14599225
• Product Code: NIQ
• UDI-Device Identifier: 07640130439146
• UDI-Public: 7640130439146
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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: 11/16/2023
• Device Model Number: 364505
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10217121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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
• Patient Sex: Unknown