MAUDE Adverse Event Report: BIOTRONIK AG Pulsar-18 T3 6/80/135; stent, superficial femoral artery

Model Number	430501
Medical Device Problem Codes	Premature Activation (1484); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 self-expandable peripheral stent system was selected for treatment of the right sfa.Following pre-dilatation and shockwave, the device was successfully advanced to the target lesion.An attempt was made to deploy the stent; however, the deployment wheel stopped moving and the stent could not be released.During withdrawal of the device, the stent partially deployed within the introducer sheath.The device was completely removed.There was no harm to the patient.

• Brand Name: Pulsar-18 T3 6/80/135
• 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: jana burger ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 50339854
• Report Number: 8043892-2026-07282
• Device Sequence Number: 14820107
• Product Code: NIP
• UDI-Device Identifier: 07640130446991
• UDI-Public: (01)07640130446991(17)290310(10)22264657
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: 430501
• Device Lot Number: 22264657
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• 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