MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/80/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430491
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a severely calcified lesion (60 percent stenosis degree) in a mildly tortuous part of the mid popliteal artery.The lesion was pre-dilated as required, and the device was positioned, but the stent did not expand.Finally, when the system was removed, the stent came out as well.
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process could be the cause for the reported event.The technical investigation confirmed that the outer shaft has been retracted by about 53.5 mm.The stent has been fully released and was returned separately.The stent is not deformed or damaged.The device shaft dimensions comply with the specifications.The distal end of the retractable shaft shows a slight bulging, most likely induced during the crossing of the target lesion.The device shaft shows no damage or irregularity besides a kink at the distal end of the handle lever which, however, may have been induced during re-packaging for the return shipment.The safety button at the handle is in the unlocked position.Upon rotating the rotating wheel, the braided shaft retracts normally.Review of the production documentation confirmed that the device was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PULSAR-18 T3 5/80/135
• 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: 21884160
• Report Number: 1028232-2025-01932
• Device Sequence Number: 11621585
• Product Code: NIP
• UDI-Device Identifier: 07640130446892
• UDI-Public: (01)07640130446892(17)2710
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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): 06/09/2025

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: 430491
• Device Catalogue Number: 430491
• Device Lot Number: 10241475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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