MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/150/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430464
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of the sfa.After implanting the stent, the delivery system was attempted to be removed from the patient.There was resistance.After back and forth several times, the tip broke off, but all devices could be retrieved together from the patient.
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 confirmed that the device tip has detached from the inner shaft and that the inner shaft has fractured 331 mm proximal to its distal end.The inner shaft fragment shows severe constriction over a length of 159 mm, caused by the application of a high tensile force, most likely induced during the attempt the pull the device from the guide wire.The constriction reaches into the glueing of the x-ray marker of the tip.It appears that due to this constriction of the inner shaft, the device tip eventually detached from the shaft.The cause for the blockage between the inner shaft and the guide wire used in the intervention remains unresolved, as the guide wire was not returned.Review of the production documentation verified 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 was identified.

• Brand Name: PULSAR-18 T3 6/150/90
• 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: 21858884
• Report Number: 1028232-2025-01888
• Device Sequence Number: 17323643
• Product Code: NIP
• UDI-Device Identifier: 07640130446625
• UDI-Public: (01)07640130446625(17)2706
• Combination Product (Y/N): N
• 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): 06/11/2025

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: 430464
• Device Catalogue Number: 430464
• Device Lot Number: 05242010
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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