MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 5/170/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430455
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment.The retractable shaft did not pull back, although the delivery wheel was turned.
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 the reported event.The technical investigation confirmed that the stent has not been released.The proximal outer shaft portion has been completely pulled into the stabilizer shaft.Consequently, the stabilizer shaft is compressed at the transition to the handle lever.The usable length of the device does not comply anymore with the specification.The handle was returned with the device hub, the stopper shaft and the inner shaft being located about 237 mm proximal to handle.The rotating wheel could not be further rotated.A reference pulsar-18 t3 was prepared with the device hub being dislocated partially outside of the handle.When turning the rotating wheel, the outer shaft moved in proximal direction together with the device hub, the stopper shaft and the inner shaft without releasing the stent.The reported event could be reproduced.The most probable root cause for the reported event is therefore related to the manufacturing process.To prevent recurrence the respective internal departments were informed about this case.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment.The retractable shaft did not pull back, although the delivery wheel was turned.

• Brand Name: PULSAR-18 T3 5/170/90
• 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: 23679493
• Report Number: 8043892-2025-11201
• Device Sequence Number: 9753955
• Product Code: NIP
• UDI-Device Identifier: 07640130446533
• UDI-Public: (01)07640130446533(17)260529(10)05230184
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Expiration Date: 05/29/2026
• Device Model Number: 430455
• Device Lot Number: 05230184
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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