MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/60/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430490
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was subjected to a 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technical investigation revealed that the stent is fully crimped under the outer shaft, i.E., the outer shaft has not been retracted.Inspection of the device revealed no damage or irregularity.In the as-returned state the red safety button at the handle was in the locked position.During the technical investigation the safety button was unlocked, and the stent was successfully released.Review of the production documentation for the product detailed above confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the procedure.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of the axillary artery.The device was inserted through left arm for a radial approach, but the stent did not deploy.The device was removed from the patient.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of the axillary artery.The device was inserted through left arm for a radial approach, but the stent did not deploy.The device was removed from the patient.

• Brand Name: PULSAR-18 T3 5/60/135
• 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: 21422090
• Report Number: 1028232-2025-00876
• Device Sequence Number: 18120986
• Product Code: NIP
• UDI-Device Identifier: 07640130446885
• UDI-Public: (01)07640130446885(17)2510
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 10/09/2025
• Device Model Number: 430490
• Device Catalogue Number: 430490
• Device Lot Number: 09224625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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