MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ASTRON 10/60/72; STENT, ILIAC

Model Number	364658
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, seven still images from the angiogram were provided by the local staff.The technical investigation revealed that the retractable shaft has been retracted by about 51 mm.Scratches were observed at the distal end of the retractable shaft, showing that the stent was eventually fully released.Stent imprints are visible on the retractable outer shaft over a length of 60 mm, confirming that the stent was mounted correctly at the time of delivery.The provided images from the angiogram were reviewed.The treatment of the left subclavian artery is visible with the pre-dilation, the implantation of the second stent and its post-dilation.The complaint device and the actual complaint event is not visible.The angiographic material does therefore not provide further relevant information regarding the root cause of the complaint.Review of the production documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.During final inspection a 100 percent visual control of the stent area is performed.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.It should be noted that the astron us stent system is indicated for use in patients with atherosclerotic disease of the iliac arteries.
Event or Problem Description
The physician intended to treat a total occlusion in the left subclavian artery.An old stent (unknown manufacturer) was present in the occluded vessel.After crossing the lesion with a 0.035 inch terumo 180 cm glidewire and pre-dilation with a 9 mm balloon catheter, the complaint device was inserted into the patient using a short 6f merit medical prelude introducer sheath.According to the physicians description, the lesion was reached with no reported issues.Once the device was positioned in the target lesion, it became apparent that there was no stent in the catheter.The complaint device was withdrawn and a second astron 10/60/72 was used to successfully finalize the intervention.

• Brand Name: ASTRON 10/60/72
• Common Device Name: STENT, ILIAC
• 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: 20658626
• Report Number: 1028232-2024-05898
• Device Sequence Number: 8502360
• Product Code: NIO
• UDI-Device Identifier: 07640130412330
• UDI-Public: (01)07640130412330(17)2706
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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 Model Number: 364658
• Device Catalogue Number: 364658
• Device Lot Number: 05244437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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