MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430489
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A dissection was found in the p2 segment of the popliteal artery, which occurred during pre-dilatation.The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment.The angio showed that the dissection was large and the vascular morphology was relatively twisted, resulting in a large resistance to the stent delivery.Eventually, the stent could not reach the lesion.
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.The technical investigation revealed that the stent was fully released and was not returned, the safety button was pressed down.The device shaft shows no damage or irregularity.The dimensions of the shaft system were measured and complies with the specification.The tip shows a severe indentation at its distal end, most likely caused by a hard, sharp-edged object, such as e.G., anatomical structure.After flushing, a 0.018 inch reference guidewire could be fully introduced with no unusual resistance.The guidewire and the introducer sheath used in the intervention were not returned.The provided image was reviewed.A device is visible in the sfa, but the resolution of the image does not allow to tell if it is the complaint device.The provided material does therefore not provide further relevant information regarding the root cause of the complaint.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During final inspection, every stent system undergoes visual inspection, and the outer shaft diameter is measured to 100 percent.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Considering the physicians event description and the findings, the root cause for the complaint event is most likely related to the patients anatomy (i.E., severely tortuous and severely calcified target lesion).It should be noted that the pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries.

• Brand Name: PULSAR-18 T3 5/40/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 21193214
• Report Number: 1028232-2025-00328
• Device Sequence Number: 17011061
• Product Code: NIP
• UDI-Device Identifier: 07640130446878
• UDI-Public: (01)07640130446878(17)2612
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 430489
• Device Catalogue Number: 430489
• Device Lot Number: 11234614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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
• Patient Sex: Unknown