MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430494
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a severely calcified lesion (90 percent stenosis degree) in a moderately tortuous part of a mid-part of a lower limb artery.After pre-dilation, the pulsar-18 t3 was advanced to the lesion and the stent was released, but no stent was visible after release.The delivery system together with the vascular sheath was withdrawn, and it was detected that the stent in the delivery system did not unfold.Another stent of same model was implanted, and the procedure was successfully completed.
Additional Manufacturer Narrative
Neither the affected device nor the angiographic material was 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.The provided image shows that the stent has been partially released by two strut rows.The retractable outer shaft has been retracted by approximately 11.5 mm.No damages or other irregularities are visible in the provided image.The proximal shaft system or the handle is not shown in the image.Review of the production for the product detailed above confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 T3 5/150/135
• 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: 21633633
• Report Number: 1028232-2025-01365
• Device Sequence Number: 7499042
• Product Code: NIP
• UDI-Device Identifier: 07640130446922
• UDI-Public: (01)07640130446922(17)2702
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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
• Device Model Number: 430494
• Device Catalogue Number: 430494
• Device Lot Number: 01244168
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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
• Patient Sex: Unknown