MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/30/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430498
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 self-expandable stent system was selected for treatment for a moderately calcified lesion (90 percent stenosis degree) in a mildly tortuous part of the mid popliteal artery.It was difficult to release the pulsar-18 t3 stent.The stent was finally released in the body, but completely stretched (approx.Double of the nominal length).To complete the intervention, a longer pulsar-18 t3 stent was implanted.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, a photograph taken from the angiogram was reviewed.The photograph shows two released stents in the popliteal artery.Geometric distortions of the stent structure are visible.The inhomogeneous radiopacity along the stent may be suggestive of focal stent compression or elongation.Unfortunately, the quality of the photograph is rather poor.The technical investigation of the affected device revealed that the outer shaft has been retracted by about 169 mm.The stent has been fully released.The stabilizer shaft is waved over a length of about 150 mm, starting about 140 mm distal to the handle lever, and has wrinkled (i.E.Is strongly deformed) at the distal end of the handle lever.Also, the handle lever is bent over its entire length.The entire system is under tension.The handle was returned with the safety button in the unlocked position.The rotating wheel cannot be further rotated.The findings show that the outer shaft has been retracted too far into the stabilizer shaft which eventually caused axial compression of the entire system.However, this damage was caused after the stent release.Review of the production documentation 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 material or manufacturing related root cause could be determined.Please note that, according to the ifu, any slack in the delivery system outside the patient could result in incorrect stent placement, potential stent compression or elongation.It should also be noted that pulsar-18 t3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (pta), e.G.Residual stenosis and dissection.

• Brand Name: PULSAR-18 T3 6/30/135
• 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: 22099051
• Report Number: 1028232-2025-02604
• Device Sequence Number: 20934781
• Product Code: NIP
• UDI-Device Identifier: 07640130446960
• UDI-Public: (01)07640130446960(17)2803
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/26/2025

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: 430498
• Device Catalogue Number: 430498
• Device Lot Number: 02251095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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