MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/200/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430496
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2025
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 (75 percent stenosis degree) a severely tortuous part of the proximal right vertebral artery.After pre-dilatation, the pulsar-18 was delivered to the lesion and released, but the distal area of the stent was twisted and shortened around 1 cm.A balloon was used to inflate the twisted area, but the stent structure was damaged.Another stent was implanted to cover the damaged area and the vessel was improved.The patient was stable.
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.In addition, a video taken from the angiogram was reviewed.The video provided shows three released stents in the sfa.At the middle stent, geometric distortions of the stent structure are recognizable.The inhomogeneous radiopacity at the distal end of the stent may be suggestive of focal stent compression or elongation.Unfortunately, the quality of the video is rather poor.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 investigations, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 T3 5/200/135
• 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: 21764141
• Report Number: 1028232-2025-01636
• Device Sequence Number: 21001855
• Product Code: NIP
• UDI-Device Identifier: 07640130446946
• UDI-Public: (01)07640130446946(17)2705
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 430496
• Device Catalogue Number: 430496
• Device Lot Number: 04243891
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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