MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430495
Medical Device Problem Codes	Activation Failure (3270); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a moderately calcified lesion (90% stenosis degree) in a moderately tortuous part of the proximal sfa.After delivering the device to the lesion, the trigger could not be moved.Another pulsar-18 t3 was used to finish 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 is event.In addition, a photograph and a video of the device were reviewed.The photograph shows the distal device portion with the guidewire inserted.The outer shaft has not been retracted.The video shows the handle of the affected device.The rotating wheel cannot be further rotated.In the as-returned state, the guidewire used in the intervention was stuck inside the affected device.Microscopic inspection showed that the distal outer shaft portion and the distal end of the stent are stuck at the device tip.The marker ring at the distal end of the outer shaft is severely deformed.The stent and the outer shaft show signs of compression.The entire shaft assembly is under tension.The diameter of the outer shaft and the usable length of the device do not comply anymore with the specification.During the investigation, the handle was opened which revealed that the rotating wheel has been rotated multiple times.The inner shaft and the stopper shaft have been pulled against the device hub and are severely deformed.The guidewire is stuck in this area.The findings indicate a sequence of unfavorable events.It appears that at some point before or during the intervention the distal end of the outer shaft has been pushed over the device tip or vice versa that the device tip has been pushed into the outer shaft.In that process, the outer shaft, the stent and the tip became stuck.Unfortunately, it cannot be reconstructed when exactly this happened.When rotating the rotating wheel, the stuck shaft-stent-tip unit was retracted which caused severe deformations at the stuck shaft-stent-tip unit and at the inner- and stopper shaft.However, to cause such damage, the rotating wheel must have been rotated multiple times with high force despite meeting resistance.Review of the production documentation confirmed that the device was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection during which the device dimensions are measured and the relevant device parts are visually controlled multiple times.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be identified.It should be noted that the ifu advises the user to stop and determine the cause before proceeding if strong resistance is felt during stent deployment.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a moderately calcified lesion (90% stenosis degree) in a moderately tortuous part of the proximal sfa.After delivering the device to the lesion, the trigger could not be moved.Another pulsar-18 t3 was used to finish the procedure.

• Brand Name: PULSAR-18 T3
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 23740558
• Report Number: 8043892-2025-12011
• Device Sequence Number: 8421248
• Product Code: NIP
• UDI-Device Identifier: 07640130446939
• UDI-Public: (01)07640130446939(17)280705(10)06253305
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2026

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: 430495
• Device Lot Number: 06253305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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