MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 T3 6/170/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After insertion of the pulsar-18 t3 self-expandable stent system, the tip fractured during delivery.The guidewire was used to remove the fractured part and another stent was used for 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 the reported event.In addition, the still image from the angiogram provided were reviewed.The still image of the angiogram show clearly the separated tip in the left iliac region of the patient.However, the fracture of the affected device during the procedure is not shown.The affected device was returned for investigation.The outer shaft has not been retracted, and the stent was not released.The device inner shaft has fractured directly proximal to the tip.A visible spiral-shaped cut has been detected at the fracture site, which has most likely been induced during the fabrication of the supplier's component.The dimensions of the shaft components comply with the specification.The stent could not be released during investigation due to dried blood residue.The handle is undamaged and shows no irregularities.The root cause for the reported event is most likely related to the manufacturing process of a component produced by a supplier.The relevant internal departments were informed about the investigation results.The supplier of the affected component was informed and acknowledged the complaint.
Event or Problem Description
After insertion of the pulsar-18 t3 self-expandable stent system, the tip fractured during delivery.The guidewire was used to remove the fractured part and another stent was used for the procedure.

• Brand Name: PULSAR-18 T3 6/170/135
• 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: 23178230
• Report Number: 8043892-2025-09181
• Device Sequence Number: 9025904
• Product Code: NIP
• UDI-Device Identifier: 07640130447035
• UDI-Public: (01)07640130447035(17)270711(10)06244629
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Model Number: 430505
• Device Lot Number: 06244629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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