MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430502
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
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
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a moderately calcified lesion (70 percent stenosis degree) in a mildly tortuous part of the mid renal artery.After pre-dilatation of the lesion in the renal artery the vessel was still not good.Therefore, the pulsar-18 t3 was used but huge resistance during delivery was experienced, the device could not cross the curve and the shaft was kinked during the procedure.
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 device shows no damages, deformations or irregularities.The diameter of the retractable shaft complies with the specification.After flushing, a 0.018 inch reference guide wire could be fully introduced with no unusual friction.The guidewire and the introducer sheath used in the intervention were not returned.The provided image was reviewed.A device is visible in the renal artery, 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.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 6/100/135
• 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: 21194326
• Report Number: 1028232-2025-00335
• Device Sequence Number: 20722791
• Product Code: NIP
• UDI-Device Identifier: 07640130447004
• UDI-Public: (01)07640130447004(17)2604
• 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 Expiration Date: 04/16/2026
• Device Model Number: 430502
• Device Catalogue Number: 430502
• Device Lot Number: 03232398
• 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: 01/17/2025
• 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: 04/18/2023
• 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