MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/40/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430499
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
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 (70 percent stenosis degree) in a severely tortuous part of the ostial sfa.The device was advanced to the lesion and the safety button was clicked.The stent was partially released, and the location could not be adjusted.Device and stent were retrieved and another stent was used to finish 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event.In addition, a photograph of the device was reviewed.The photograph provided shows that the outer shaft has been retracted.The stent has been fully released and is located at the distal end of the device shaft.The technical investigation confirmed that the stent has been fully released.The stent was returned separately and shows no damage or irregularity.The distal end of the retractable shaft is located about 13 mm distal to the stopper shaft.The marker ring at the distal end of the retractable shaft is severely deformed.The retractable shaft is compressed about 8 mm proximal to its distal end.In addition, the distal inner shaft portion is severely deformed (i.E.Twisted) over a length of about 59 mm and kinked at several locations.However, the kinks are not present in the photograph provided and are thus not complaint-related.Moreover, both the stabilizer shaft and the handle lever are bent.Outside of the deformed zones, the shaft dimensions comply with the specifications.Dissection of the device revealed a large amount of foreign material inside the guidewire lumen.The foreign material was subjected to sem analysis and edx analysis which confirmed that the foreign material is a part of a guidewire.It is possible that a damaged guidewire has contributed to the reported event.However, due to the state of the device, the event cannot be reconstructed.Unfortunately, both the introducer sheath and the guidewire used in the intervention were not returned.Review of the production documentation confirmed that the device in question was manufactured according to specifications and passed all in-process and final inspections during which a 100 percent control of the guide wire lumen viability is performed.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.Please note that the ifu advises the user to exercise care during handling to reduce the possibility of releasing the stent prematurely, accidental breakage, bending or kinking of the catheter shaft.
Event or Problem Description
The pulsar-18 t3 peripheral self-expandable stent system was selected for treatment of a severely calcified lesion (70 percent stenosis degree) in a severely tortuous part of the ostial sfa.The device was advanced to the lesion and the safety button was clicked.The stent was partially released, and the location could not be adjusted.Device and stent were retrieved and another stent was used to finish the procedure.

• Brand Name: PULSAR-18 T3 6/40/135
• 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: 21243150
• Report Number: 1028232-2025-00433
• Device Sequence Number: 3580416
• Product Code: NIP
• UDI-Device Identifier: 07640130446977
• UDI-Public: (01)07640130446977(17)2604
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 04/03/2025

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: 04/26/2026
• Device Model Number: 430499
• Device Catalogue Number: 430499
• Device Lot Number: 03233212
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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